Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-22 @ 4:51 PM
Study NCT ID:
NCT03789656
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2018-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@crinetics.com', 'phone': '+1 858-450-6464', 'title': 'Crinetics Clinical Trials', 'organization': 'Crinetics Pharmaceuticals, Inc'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that PIs cannot publish until the multi-center publication is first published. If no multi-center publication is published within 18 months of the completion date, the PI may publish their results, provided that the Sponsor is given the opportunity to review the proposed publication in advance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored until the end of the 4-week follow-up period (up to 17 weeks total).', 'description': 'Some participants received uptitrated dose during the treatment period and are therefore counted in multiple dosing groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose 5 mg', 'description': 'Adverse event occurred when subject was receiving 5 mg dose paltusotine', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose 10 mg', 'description': 'Adverse event occurred when subject was receiving 10 mg dose paltusotine', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 23, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 20 mg', 'description': 'Adverse event occurred when subject was receiving 20 mg dose paltusotine', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 24, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Dose 30 mg', 'description': 'Adverse event occurred when subject was receiving 30 mg dose paltusotine', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 15, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose 40 mg', 'description': 'Adverse event occurred when subject was receiving 40 mg dose paltusotine', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 19, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sleep apnea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Subjects in Group 1 previously treated with octreotide or lanreotide'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.034', 'groupId': 'OG000', 'lowerLimit': '-0.107', 'upperLimit': '1.07'}]}]}], 'analyses': [{'pValue': '0.6285', 'groupIds': ['OG000'], 'groupDescription': 'The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '13 Weeks', 'description': 'Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).', 'unitOfMeasure': 'ng/mL x ULN', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': 'Eligibility to enter this group was specified as: Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was \\>ULN, and the V2 value was ≤2.5 × ULN)'}, {'id': 'OG001', 'title': 'Group 4', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ULN)'}, {'id': 'OG002', 'title': 'Group 5', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'W13/EoT (Response)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'W13/EoT (No Response)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3877', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'exact binomial test assuming the null pr', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Null proportion = 0.5'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was limited to only subjects in Groups 3, 4 and 5 who started the study with IGF-1 ≤ULN.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Partial responders on a stable treatment of octreotide LAR or lanreotide depot (at least one Screening IGF-1 value must be \\>ULN, and the V2 value must be ≤2.5×ULN)'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Partial responders on a stable combination treatment of SSA (i.e., octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least one Screening IGF-1 value must be \\>ULN, and the V2 value must be ≤2.5×ULN)'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Eligibility to enter this group was specified as: Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist(bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was\\>ULN, and the V2 value was≤2.5 × ULN)'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist(bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ ULN)'}, {'id': 'OG004', 'title': 'Group 5', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN)'}], 'classes': [{'title': 'Baseline (Response)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'W13/EoT (Response)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'W13/EoT (No Response)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was estimated for all the subjects in the Full Analysis Set (FAS)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Subjects in Group 1 previously treated with octreotide or lanreotide'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.335', 'groupId': 'OG000', 'lowerLimit': '1.078', 'upperLimit': '1.471'}]}]}, {'title': 'Week 13 (Visit 14)/ End of Treatment', 'categories': [{'measurements': [{'value': '1.343', 'groupId': 'OG000', 'lowerLimit': '1.169', 'upperLimit': '1.448'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '13 Weeks', 'description': 'Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).', 'unitOfMeasure': 'ng/mL x ULN', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Partial responders on a stable treatment of octreotide long-acting release (LAR) or lanreotide depot (at least 1 Screening IGF-1 value was \\> upper limit of normal (ULN), and the V2 value was ≤2.5× ULN)'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was \\>ULN, and the V2 value was ≤2.5 × ULN).'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ULN).'}, {'id': 'FG003', 'title': 'Group 4', 'description': 'Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN).'}, {'id': 'FG004', 'title': 'Group 5', 'description': 'Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and pegvisomant (mean of Screening IGF-1 values were ≤ULN).'}], 'periods': [{'title': 'Screening Period: up to 6 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period: up to 13 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treatment Period started with first dose of study drug (10 mg) at V3, approx. 4 wks after last dose of standard acromegaly treatment.\n\nDuring V6/W4 and V9/W7, the dose was titrated up (blinded), if subject was eligible. Dose increase in 10 mg increments were allowed only at V6/W4 (10 mg to 20 mg), V9/W7 (10 mg to 20 mg, or 20 mg to 30 mg), and V12/W10 (10 mg to 20 mg, 20 mg to 30 mg, or 30 mg to 40 mg). No further up-titration was allowed. Daily dose did not exceed 40 mg.', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'Treatment Period started with first dose of study drug (10 mg) at V3, approx. 4 wks after last dose of standard acromegaly treatment.\n\nDuring V6/W4 and V9/W7, the dose was titrated up (blinded), if subject was eligible. Dose increase in 10 mg increments were allowed only at V6/W4 (10 mg to 20 mg), V9/W7 (10 mg to 20 mg, or 20 mg to 30 mg), and V12/W10 (10 mg to 20 mg, 20 mg to 30 mg, or 30 mg to 40 mg). No further up-titration was allowed. Daily dose did not exceed 40 mg.', 'groupId': 'FG001', 'numSubjects': '10'}, {'comment': 'Treatment Period started with first dose of study drug (10 mg) at V3, approx. 4 wks after last dose of standard acromegaly treatment.\n\nDuring V6/W4 and V9/W7, the dose was titrated up (blinded), if subject was eligible. Dose increase in 10 mg increments were allowed only at V6/W4 (10 mg to 20 mg), V9/W7 (10 mg to 20 mg, or 20 mg to 30 mg), and V12/W10 (10 mg to 20 mg, 20 mg to 30 mg, or 30 mg to 40 mg). No further up-titration was allowed. Daily dose did not exceed 40 mg.', 'groupId': 'FG002', 'numSubjects': '5'}, {'comment': 'Treatment Period started with first dose of study drug (10 mg) at V3, approx. 4 wks after last dose of standard acromegaly treatment.\n\nDuring V6/W4 and V9/W7, the dose was titrated up (blinded), if subject was eligible. Dose increase in 10 mg increments were allowed only at V6/W4 (10 mg to 20 mg), V9/W7 (10 mg to 20 mg, or 20 mg to 30 mg), and V12/W10 (10 mg to 20 mg, 20 mg to 30 mg, or 30 mg to 40 mg). No further up-titration was allowed. Daily dose did not exceed 40 mg.', 'groupId': 'FG003', 'numSubjects': '4'}, {'comment': 'Treatment Period started with first dose of study drug (10 mg) at V3, approx. 4 wks after last dose of standard acromegaly treatment.\n\nDuring V6/W4 and V9/W7, the dose was titrated up (blinded), if subject was eligible. Dose increase in 10 mg increments were allowed only at V6/W4 (10 mg to 20 mg), V9/W7 (10 mg to 20 mg, or 20 mg to 30 mg), and V12/W10 (10 mg to 20 mg, 20 mg to 30 mg, or 30 mg to 40 mg). No further up-titration was allowed. Daily dose did not exceed 40 mg.', 'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Prohibited Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COVID-19 Lockdown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unable to Travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period: up to 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 45 subjects were planned to be enrolled in the study. 47 subjects participated in the study.', 'preAssignmentDetails': 'A total of 45 subjects were planned to be enrolled in the study. 47 subjects participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Efficacy Analysis Set - Primary Analysis Population for all efficacy analyses. Only includes participants from Group 1.\n\nEligibility to enter this group was specified as: Partial responders on a stable treatment of octreotide long-acting release (LAR) or lanreotide depot (at least 1 Screening IGF-1 value was greater than upper limit of normal (ULN), and the V2 value was ≤2.5× ULN)'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Eligibility to enter this group was specified as: Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was \\>ULN, and the V2 value was ≤2.5 × ULN)'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ULN)'}, {'id': 'BG003', 'title': 'Group 4', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN)'}, {'id': 'BG004', 'title': 'Group 5', 'description': 'Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and pegvisomant (mean of Screening IGF-1 values were\n\n≤ULN).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], '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': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, y, median (range)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '71'}, {'value': '52.5', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '70'}, {'value': '51.0', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '69'}, {'value': '56.0', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '67'}, {'value': '38.0', 'groupId': 'BG004', 'lowerLimit': '35', 'upperLimit': '66'}, {'value': '51.0', 'groupId': 'BG005', 'lowerLimit': '31', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'description': '(range)', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '34', '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/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'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'}]}]}, {'title': 'Romania', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Serbia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Slovakia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'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': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'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'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '173.95', 'groupId': 'BG000', 'lowerLimit': '166.50', 'upperLimit': '178.50'}, {'value': '167.75', 'groupId': 'BG001', 'lowerLimit': '160.00', 'upperLimit': '173.00'}, {'value': '173.00', 'groupId': 'BG002', 'lowerLimit': '164.00', 'upperLimit': '176.00'}, {'value': '169.45', 'groupId': 'BG003', 'lowerLimit': '168.45', 'upperLimit': '179.65'}, {'value': '157.50', 'groupId': 'BG004', 'lowerLimit': '155.50', 'upperLimit': '169.00'}, {'value': '170.25', 'groupId': 'BG005', 'lowerLimit': '165.00', 'upperLimit': '176.10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Source missing for one participant, data removed and noted as protocol deviation.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '90.95', 'groupId': 'BG000', 'lowerLimit': '76.05', 'upperLimit': '103.60'}, {'value': '84.95', 'groupId': 'BG001', 'lowerLimit': '75.00', 'upperLimit': '117.00'}, {'value': '87.30', 'groupId': 'BG002', 'lowerLimit': '79.70', 'upperLimit': '88.20'}, {'value': '107', 'groupId': 'BG003', 'lowerLimit': '88.75', 'upperLimit': '114.35'}, {'value': '77.50', 'groupId': 'BG004', 'lowerLimit': '59', 'upperLimit': '82.40'}, {'value': '87.15', 'groupId': 'BG005', 'lowerLimit': '75.10', 'upperLimit': '104.20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Source missing for one participant, data removed and noted as protocol deviation.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '29.25', 'groupId': 'BG000', 'lowerLimit': '26.30', 'upperLimit': '34.15'}, {'value': '30.30', 'groupId': 'BG001', 'lowerLimit': '27.90', 'upperLimit': '38.10'}, {'value': '28.50', 'groupId': 'BG002', 'lowerLimit': '28.20', 'upperLimit': '30.40'}, {'value': '34.85', 'groupId': 'BG003', 'lowerLimit': '29.55', 'upperLimit': '37.25'}, {'value': '31.20', 'groupId': 'BG004', 'lowerLimit': '20.70', 'upperLimit': '34.10'}, {'value': '29.95', 'groupId': 'BG005', 'lowerLimit': '26.50', 'upperLimit': '34.80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilogram(s)/square meter', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Source missing for one participant, data removed and noted as protocol deviation.'}, {'title': 'Ring Size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'BG000', 'lowerLimit': '9.5', 'upperLimit': '14.5'}, {'value': '12.0', 'groupId': 'BG001', 'lowerLimit': '9.0', 'upperLimit': '12.0'}, {'value': '11.0', 'groupId': 'BG002', 'lowerLimit': '10.0', 'upperLimit': '12.0'}, {'value': '12.5', 'groupId': 'BG003', 'lowerLimit': '9.5', 'upperLimit': '19.0'}, {'value': '8.0', 'groupId': 'BG004', 'lowerLimit': '8.0', 'upperLimit': '9.0'}, {'value': '12.0', 'groupId': 'BG005', 'lowerLimit': '9.0', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Finger size is an objective measure of soft tissue over-growth and is assessed using the US Ring Size Scale. Measurements are assessed on an increasing scale of US ring sizes scored from 1-17 (smallest to largest), with an increase in ring size between consecutive visits representing increased peripheral swelling. Ring sizers (Tool jewelry sizing tools) were provided to the sites, and sites were instructed to use the same hand and finger at each visit.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Source missing for one participant, data removed and noted as protocol deviation.'}, {'title': 'IGF-1 (x ULN) at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1.335', 'groupId': 'BG000', 'lowerLimit': '1.078', 'upperLimit': '1.471'}, {'value': '1.400', 'groupId': 'BG001', 'lowerLimit': '1.214', 'upperLimit': '1.650'}, {'value': '0.922', 'groupId': 'BG002', 'lowerLimit': '0.864', 'upperLimit': '0.928'}, {'value': '0.659', 'groupId': 'BG003', 'lowerLimit': '0.600', 'upperLimit': '0.842'}, {'value': '0.909', 'groupId': 'BG004', 'lowerLimit': '0.806', 'upperLimit': '0.964'}, {'value': '1.214', 'groupId': 'BG005', 'lowerLimit': '0.965', 'upperLimit': '1.466'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL x ULN', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Growth Hormone Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0.6907', 'groupId': 'BG000', 'lowerLimit': '0.4910', 'upperLimit': '1.5545'}, {'value': '1.0490', 'groupId': 'BG001', 'lowerLimit': '0.5118', 'upperLimit': '1.6127'}, {'value': '0.8733', 'groupId': 'BG002', 'lowerLimit': '0.7088', 'upperLimit': '1.5585'}, {'value': '0.1976', 'groupId': 'BG003', 'lowerLimit': '0.1518', 'upperLimit': '0.6460'}, {'value': '2.8763', 'groupId': 'BG004', 'lowerLimit': '0.1403', 'upperLimit': '10.2843'}, {'value': '0.8733', 'groupId': 'BG005', 'lowerLimit': '0.4688', 'upperLimit': '1.6127'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nanogram(s)/milliliter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'IGFBP-3', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0.803', 'groupId': 'BG000', 'lowerLimit': '0.725', 'upperLimit': '0.886'}, {'value': '0.789', 'groupId': 'BG001', 'lowerLimit': '0.736', 'upperLimit': '0.899'}, {'value': '0.684', 'groupId': 'BG002', 'lowerLimit': '0.668', 'upperLimit': '0.693'}, {'value': '0.716', 'groupId': 'BG003', 'lowerLimit': '0.662', 'upperLimit': '0.754'}, {'value': '0.585', 'groupId': 'BG004', 'lowerLimit': '0.540', 'upperLimit': '0.788'}, {'value': '0.786', 'groupId': 'BG005', 'lowerLimit': '0.687', 'upperLimit': '0.882'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Of the 47 participants who received CRN00808-03, 42 participants completed the trial, 4 participants withdrew from treatment period, and 1 participant withdrew consent during follow up. No participants withdrew due to adverse events.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-07', 'size': 1158991, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-22T07:07', 'hasProtocol': True}, {'date': '2020-10-01', 'size': 629644, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-22T07:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2021-07-27', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2018-12-27', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2018-12-27', 'dispFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-26', 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level', 'timeFrame': '13 Weeks', 'description': 'Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)', 'timeFrame': '13 Weeks', 'description': 'The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT'}, {'measure': 'Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN', 'timeFrame': '13 Weeks', 'description': 'Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acromegaly', 'ACROBAT', 'EDGE', 'Paltusotine'], 'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '36792844', 'type': 'DERIVED', 'citation': 'Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7.'}]}, 'descriptionModule': {'briefSummary': 'An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects 18 to 75 years of age\n2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens\n3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control\n4. Willing to provide signed informed consent\n\nExclusion Criteria:\n\n1. Treatment naïve acromegaly subjects\n2. Prior treatment with paltusotine\n3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.\n4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years\n5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer\n6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result\n7. History of alcohol or substance abuse in the past 12 months\n8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study\n9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities\n10. Subjects with symptomatic cholelithiasis\n11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study\n12. Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg\n13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)"}, 'identificationModule': {'nctId': 'NCT03789656', 'briefTitle': 'An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crinetics Pharmaceuticals Inc.'}, 'officialTitle': 'An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)', 'orgStudyIdInfo': {'id': 'CRN00808-03'}, 'secondaryIdInfos': [{'id': '2018-002230-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paltusotine', 'interventionNames': ['Drug: Paltusotine']}], 'interventions': [{'name': 'Paltusotine', 'type': 'DRUG', 'otherNames': ['CRN00808'], 'description': 'Paltusotine, capsules, once daily by mouth', 'armGroupLabels': ['Paltusotine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Gonda Diabetes Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Northwest Pituitary Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Endocrinology Associates', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Curitiba', 'country': 'Brazil', 'facility': 'CETI - Centro de Estudos em Terapias Inovadoras', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'CPQuali Pesquisa Clinica', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'LMU Clinic of University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Evangelismos"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Gennimatas"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Laiko"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Athens "Ippokratio"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Military Health Center, Division of Endocrinology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University Faculty of Medicine', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs Medical School', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Takapuna', 'country': 'New Zealand', 'facility': 'Waitemata District Health Board, North Shore Hospital', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}, {'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Endocrine, Diabetes and Research Centre, Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'National Institute of Endocrinology "C. I. Parhon"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'University Hospital Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry and Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crinetics Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}