Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 4:04 PM
Study NCT ID:
NCT03364335
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2017-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BCannon@nusirt.com', 'phone': '6156567898', 'title': 'Barbara Cannon', 'organization': 'NuSirt Biopharma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: Placebo', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 14, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 19, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 12, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 21, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Body Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.121', 'spread': '3.6241', 'groupId': 'OG000'}, {'value': '0.674', 'spread': '3.2286', 'groupId': 'OG001'}, {'value': '-0.489', 'spread': '3.9041', 'groupId': 'OG002'}, {'value': '-0.929', 'spread': '4.5533', 'groupId': 'OG003'}, {'value': '-0.552', 'spread': '2.5924', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5461', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0364', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0156', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0349', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'The percentage body weight change from baseline to Day 168 was evaluated.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population.'}, {'type': 'SECONDARY', 'title': 'Change in Absolute Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.126', 'spread': '3.5903', 'groupId': 'OG000'}, {'value': '0.678', 'spread': '3.2502', 'groupId': 'OG001'}, {'value': '-0.460', 'spread': '4.0352', 'groupId': 'OG002'}, {'value': '-0.870', 'spread': '4.5445', 'groupId': 'OG003'}, {'value': '-0.461', 'spread': '2.7583', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5348', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0379', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0464', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'The change in absolute body weight from baseline to day 168 was evaluated.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With ≥5% Body Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group."}, {'pValue': '0.2646', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group."}, {'pValue': '0.0749', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group."}, {'pValue': '0.6758', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 168', 'description': 'The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.043', 'spread': '5.5591', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '5.5152', 'groupId': 'OG001'}, {'value': '-1.060', 'spread': '5.5564', 'groupId': 'OG002'}, {'value': '-1.841', 'spread': '4.7654', 'groupId': 'OG003'}, {'value': '0.637', 'spread': '5.7908', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.9656', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.4254', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.1276', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.5937', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '20.33', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '20.96', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '20.01', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '16.74', 'groupId': 'OG003'}, {'value': '-6.6', 'spread': '23.48', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.6513', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.4354', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0310', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'Changes in total cholesterol was examined by standard blood chemistry.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '7.43', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.59', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '6.40', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '8.21', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '7.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4644', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.8573', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.8167', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.9223', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 168', 'description': 'Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '15.40', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '16.86', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '15.81', 'groupId': 'OG002'}, {'value': '-5.5', 'spread': '11.77', 'groupId': 'OG003'}, {'value': '-11.6', 'spread': '19.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6574', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.8971', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.6317', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0341', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 168 days', 'description': 'Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '45.43', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '56.42', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '51.93', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '47.02', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '52.03', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.3720', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.2302', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.1377', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.4295', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 168', 'description': 'The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '9.35', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '9.59', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '12.43', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '10.87', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6726', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.7934', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.5485', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.3676', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'Change in plasma glucose was examined through standard fasting blood chemistry.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.167', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.165', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.198', 'groupId': 'OG003'}, {'value': '0.09', 'spread': '0.177', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1653', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.1970', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0608', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.1583', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 168', 'description': 'Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '9.57', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '8.10', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '9.16', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '7.48', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0524', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.5221', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.3702', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.5426', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'Diastolic blood pressure was measured by standard blood pressure monitor.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '12.21', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '9.12', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '9.31', 'groupId': 'OG003'}, {'value': '-3.5', 'spread': '9.29', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1843', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.4411', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.6991', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.3721', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 168', 'description': 'Change in Systolic blood pressure was assessed in patients from baseline to Day 168', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'OG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'OG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'OG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'OG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '2.401', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '3.633', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '3.385', 'groupId': 'OG002'}, {'value': '0.56', 'spread': '6.624', 'groupId': 'OG003'}, {'value': '0.12', 'spread': '3.551', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0318', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.3827', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.0050', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.'}, {'pValue': '0.1045', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive Statistics for Secondary Endpoint - hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'FG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'FG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'FG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'FG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of five treatment arms in the ratio of 1:1:1:1:1(A:B:C:D:E). The randomization was stratified by a maximum of 70% female with a BMI range between 30 kg/m2 and 45 kg/m2', 'preAssignmentDetails': 'The discrepancy in the number of enrolled subjects and the actual number that started the study is because some of the enrolled subjects did not start the study for the following reasons: they moved, were not compliant with investigator request or were sent on active military duty.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '258', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: Placebo'}, {'id': 'BG001', 'title': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID'}, {'id': 'BG002', 'title': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID'}, {'id': 'BG003', 'title': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'BG004', 'title': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil\n\nLeucine: 1100 mg BID\n\nSildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID\n\nMetformin: Metformin 500 mg BID'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '258', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.29', 'spread': '11.30', 'groupId': 'BG000'}, {'value': '40.94', 'spread': '11.14', 'groupId': 'BG001'}, {'value': '39.55', 'spread': '11.14', 'groupId': 'BG002'}, {'value': '41.36', 'spread': '12.66', 'groupId': 'BG003'}, {'value': '42.89', 'spread': '10.70', 'groupId': 'BG004'}, {'value': '41.20', 'spread': '11.36', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '173', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '198', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '198', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '101.67', 'spread': '13.856', 'groupId': 'BG000'}, {'value': '105.05', 'spread': '15.568', 'groupId': 'BG001'}, {'value': '107.16', 'spread': '17.962', 'groupId': 'BG002'}, {'value': '100.18', 'spread': '16.991', 'groupId': 'BG003'}, {'value': '104.50', 'spread': '17.405', 'groupId': 'BG004'}, {'value': '103.74', 'spread': '16.49', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '35.773', 'spread': '3.31', 'groupId': 'BG000'}, {'value': '37.179', 'spread': '4.28', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '4.20', 'groupId': 'BG002'}, {'value': '36.425', 'spread': '4.13', 'groupId': 'BG003'}, {'value': '37.152', 'spread': '4.23', 'groupId': 'BG004'}, {'value': '36.89', 'spread': '4.08', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '110.40', 'spread': '10.998', 'groupId': 'BG000'}, {'value': '112.91', 'spread': '11.466', 'groupId': 'BG001'}, {'value': '116.02', 'spread': '12.411', 'groupId': 'BG002'}, {'value': '111.17', 'spread': '13.291', 'groupId': 'BG003'}, {'value': '112.93', 'spread': '13.311', 'groupId': 'BG004'}, {'value': '112.71', 'spread': '12.39', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Subjects who met the inclusion criteria, with BMI between 30kg/m2 and 45kg/m2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-04', 'size': 1130876, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-23T14:11', 'hasProtocol': True}, {'date': '2017-12-04', 'size': 3245200, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-23T14:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This is a double blind, placebo controlled trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2017-11-30', 'resultsFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Body Weight Change', 'timeFrame': 'Baseline to Day 168', 'description': 'The percentage body weight change from baseline to Day 168 was evaluated.'}], 'secondaryOutcomes': [{'measure': 'Change in Absolute Body Weight', 'timeFrame': 'Baseline to Day 168', 'description': 'The change in absolute body weight from baseline to day 168 was evaluated.'}, {'measure': 'Change in Percentage of Patients With ≥5% Body Weight Loss', 'timeFrame': 'Baseline to Day 168', 'description': 'The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline to Day 168', 'description': 'The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'Baseline to Day 168', 'description': 'Changes in total cholesterol was examined by standard blood chemistry.'}, {'measure': 'Change in HDL Cholesterol', 'timeFrame': 'Baseline, Day 168', 'description': 'Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.'}, {'measure': 'Change in LDL Cholesterol', 'timeFrame': 'Baseline, 168 days', 'description': 'Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'Baseline, Day 168', 'description': 'The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.'}, {'measure': 'Change in Plasma Glucose', 'timeFrame': 'Baseline to Day 168', 'description': 'Change in plasma glucose was examined through standard fasting blood chemistry.'}, {'measure': 'Change in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Day 168', 'description': 'Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline to Day 168', 'description': 'Diastolic blood pressure was measured by standard blood pressure monitor.'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline, Day 168', 'description': 'Change in Systolic blood pressure was assessed in patients from baseline to Day 168'}, {'measure': 'Change in Inflammatory Markers', 'timeFrame': 'Baseline to Day 168', 'description': 'hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).', 'detailedDescription': 'This is a randomized, 24-week, placebo-controlled, double-blind study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of five study arms.\n\nThe primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24) receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives will also assess changes in absolute body weight, percentage of patients with ≥5% body weight loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200 and NS-0300.\n\nPatients will have one screening visits which will determine their eligibility based on lab tests. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 24 weeks. Patients will return to the clinic each month for lab tests, and routine examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Maximum of 70% female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 and ≤65 at study entry.\n2. Is male, or female and, if female, meets all of the following criteria:\n\n 1. Not breastfeeding\n 2. Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit \\[β-hCG\\]) at Screening/Visit 1 (Day-7/Week-1) (not required for hysterectomized females)\n 3. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods \\[male condom with spermicide, with or without cervical cap or diaphragm\\], implants, injectables, oral contraceptives \\[must have been using for at least the last 3 months\\], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study\n3. Stable body weight (±5%) and health over the last 3 months.\n4. Has a BMI between 30 kg/m2 and 45 kg/m2\n5. Stable diet within the last three months\n6. Subjects on antidepressants, excluding those listed in the exclusion criteria, must have been on a stable dose regiment for at least 3 months prior to study enrollment and maintain stable dose during the study\n7. Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal, not clinically significant or with abnormalities consistent with obesity\n8. Is able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 \\[HIPAA\\] legislation), communicate with the investigator, and understand and comply with protocol requirements.\n\nExclusion Criteria:\n\n1. Diagnosis of diabetes or on a diabetes medication\n2. HbA1c ≥6.5% at Screening/Visit 1 (Day-7/Week-1)\n3. Severe renal impairment (eGFR \\< 45 mg/mL/1.73 m2) and/or patients with acute or chronic metabolic acidosis. Acidosis is defined as \\>25mmol/L computed without K.\n\n Normal is 8- 16, but acidosis is \\>25\n4. Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study:\n\n 1. Use of any anti-diabetes medication including metformin and any combination drug that contains metformin\n 2. Sildenafil\n 3. Tadalafil\n 4. Vardenafil\n 5. OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine)\n 6. Riociguat (guanylate cyclase stimulant)\n 7. Alpha blockers\n 8. Nitrates (e.g. oral nitrates, sublingual nitroglycerine and nitroglycerine patches)\n 9. Potent CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)\n 10. All antihypertensive medications\n 11. Medications associated with weight changes\n\n * Drugs approved for the treatment of obesity\n * Cypropheptadine or medroxyprogesterone\n * Atypical anti-psychotic drugs\n * Tricyclic antidepressants\n * Lithium, MAO's, glucocorticoids\n * SSRI's or SNRI's\n * Antiepileptic drugs\n * Systemic corticosteroids\n * Stimulants e.g. amphetamines\n 12. Any dietary supplement that is labeled for weight management or maintenance of healthy weight\n5. Diagnosis or evidence of eating disorders\n6. ≥ 5% weight change in the last 3 months\n7. Subjects who have had bariatric surgery\n8. An infection requiring antibiotic treatment within the last 30 days\n9. Any chronic inflammatory disease, e.g. inflammatory bowel disease rheumatoid arthritis, vasculitis, systemic lupus erythematosus\n10. Diseases interfering with metabolism (including metabolism of branched chain amino acids) and/or ingestive behavior (myxedema, Cushing's disease, diabetes, schizophrenia, major psychoses, maple syrup urine disease, unmanaged depression etc.)\n11. History of alcohol abuse (defined ≥ 21 drinks per week for males and \\> 14 drinks per week for females), within the past 3 months or failure on urinary drug screen\n12. History of substance abuse (including alcohol abuse as defined above) in the past 12 months or a positive screen for drugs (opioids without a prescription), including marijuana, of abuse or alcohol at screening.\n13. Has received any investigational drug within 3 months of Screening.\n14. Has donated blood within 3 months before Screening or is planning to donate blood during the study (due to HbA1c reading at screening)\n15. Other medical conditions that may diminish life expectancy to \\<2 years, including known cancers\n16. Have been diagnosed with metastatic carcinomas in the last 5 years\n17. Has known allergies or hypersensitivity to metformin, sildenafil or leucine\n18. Have suffered myocardial infarction, stroke, arrhythmia in the last 6 months\n19. Resting hypotension (BP \\<90/50 mmHg) or severe hypertension (BP \\>170/110 mmHg) If both or one of the parameters for diastolic or systolic BP is meet\n20. Cardiac failure or coronary artery disease causing unstable angina\n21. History or evidence at screening of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure\n22. At risk for priapism due to anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease) or other conditions that predispose to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia)\n23. Clinical evidence of hepatic impairment and/or ALT/AST \\>5X ULN\n24. Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or NuSirt Biopharma.\n25. Is employed by NuSirt Biopharma (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study)."}, 'identificationModule': {'nctId': 'NCT03364335', 'briefTitle': 'The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'NuSirt Biopharma'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of Effects of Two Fixed-dose Leucine-sildenafil Combinations (NS-0300) or Two Fixed-dose Leucine-sildenafil-metformin Combinations (NS-0200) Versus Placebo on Body Weight in Obesity', 'orgStudyIdInfo': {'id': 'NS-WM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each dose of placebo will consist of three tablets, identical in appearance to those used in the two active treatment arms, containing 93.5% Microcrystalline cellulose PH 102, 5.0% Crospovidone XL 10, 1.0% Silica gel (Syloid 244), 0.5% Magnesium stearate I MF3V for the leucine matched placebo and 99.5% Avicel PH200 , 0.5% magnesium stearate (w/w) and Opadry II White coating 3% weight gain for the sildenafil matched placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Leu Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil', 'interventionNames': ['Drug: Leu Sil 1.0mg', 'Drug: Leu Sil 4.0mg']}, {'type': 'EXPERIMENTAL', 'label': 'Leu Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil', 'interventionNames': ['Drug: Leu Sil 1.0mg', 'Drug: Leu Met Sil 1.0mg']}, {'type': 'EXPERIMENTAL', 'label': 'Leu Met Sil 1.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil', 'interventionNames': ['Drug: Leu Sil 1.0mg', 'Drug: Leu Sil 4.0mg', 'Drug: Leu Met Sil 4.0mg']}, {'type': 'EXPERIMENTAL', 'label': 'Leu Met Sil 4.0mg', 'description': '3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil', 'interventionNames': ['Drug: Leu Sil 1.0mg', 'Drug: Leu Met Sil 1.0mg', 'Drug: Leu Met Sil 4.0mg']}], 'interventions': [{'name': 'Leu Sil 1.0mg', 'type': 'DRUG', 'otherNames': ['NS-0300-1.0'], 'description': 'Leu 1100 mg + 1mg Sil BID', 'armGroupLabels': ['Leu Met Sil 1.0mg', 'Leu Met Sil 4.0mg', 'Leu Sil 1.0mg', 'Leu Sil 4.0mg']}, {'name': 'Leu Sil 4.0mg', 'type': 'DRUG', 'otherNames': ['NS-0300-4.0'], 'description': 'Leu 1100 mg + 4mg Sil BID', 'armGroupLabels': ['Leu Met Sil 1.0mg', 'Leu Sil 1.0mg']}, {'name': 'Leu Met Sil 1.0mg', 'type': 'DRUG', 'otherNames': ['NS-0200-1.0'], 'description': 'Leu 1100 mg + Met 500mg + 1mg Sil BID', 'armGroupLabels': ['Leu Met Sil 4.0mg', 'Leu Sil 4.0mg']}, {'name': 'Leu Met Sil 4.0mg', 'type': 'DRUG', 'otherNames': ['NS-0200-4.0'], 'description': 'Leu 1100 mg + Met 500mg + 4mg Sil BID', 'armGroupLabels': ['Leu Met Sil 1.0mg', 'Leu Met Sil 4.0mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'AMR', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'ACR', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60602', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Synexus', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials Management', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Synexus', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'AMR', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rapid Medical Research', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical Research South', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37040', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Premier', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Synexus', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Synexus', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84088', 'city': 'Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'ACR', 'geoPoint': {'lat': 40.49995, 'lon': -111.95077}}], 'overallOfficials': [{'name': 'Michael B Zemel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'NuSirt Biopharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuSirt Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}