Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 1:35 PM
Study NCT ID:
NCT05891834
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2023-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2025-06-04', 'completionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-26', 'dispFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline in body weight at Week 16 for INV-202 versus placebo'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of INV-202 on weight (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean percent change from baseline at each site visit for the following:\n\nPercent change in weight'}, {'measure': 'To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline at each site visit for the following:\n\nChange in waist circumference'}, {'measure': 'To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline at each site visit for the following:\n\nChange in lipids (LDL, VLDL, HDL, total cholesterol, ApoB) results by central laboratory testing'}, {'measure': 'To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline at each site visit for the following:\n\nChange in markers of glucose control (HgbA1C) results by central laboratory testing'}, {'measure': 'To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline at each site visit for the following:\n\nChange in markers of glucose control (insulin) results by central laboratory testing'}, {'measure': 'To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)', 'timeFrame': 'Week 16', 'description': 'Mean change from baseline at each site visit for the following:\n\nChange in markers of glucose control (C-peptide) results by central laboratory testing'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '41038215', 'type': 'DERIVED', 'citation': 'Knop FK, Kunos G, Dicker D, Paquette JS, Aronne L, Frenkel O, Holst-Hansen T, Lalonde K, Lee J, Crater G; trial investigators. Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):911-923. doi: 10.1016/S2213-8587(25)00216-5. Epub 2025 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.', 'detailedDescription': 'This will be a 2-part study. Part A will be a randomized, double-blind, placebo-controlled, dose ranging, multicenter study assessing the efficacy, safety, tolerability, and PK of INV-202 for the treatment of adult participants with obesity (BMI 30 kg/m2) and metabolic syndrome.\n\nAn informed consent form (ICF) must be signed by the participant before any study-related procedures are performed.\n\nEach participant will be allowed 1 retest during the screening period if they have an abnormal test result not meeting eligibility criteria that is deemed transient by the investigator. Participants who did not meet all eligibility criteria may be re-screened once, with approval of the medical monitor.\n\nParticipants will return to the study site at Weeks 4, 8, 12 and 16. At these visits, the same assessment as baseline will be completed.\n\nDuring Part A, a subset of approximately 20 to 30 participants from an estimated 3 to 4 study sites will have DEXA performed at baseline and Week 16 for exploratory assessments of change in total body fat percentage and skeletal muscle mass. Additional exploratory measures will include lung function with oscillometry. Any participant who withdraws from Part A before completing treatment will be requested to return for an early termination visit, at which time the procedures normally scheduled for the Week 16 visit will be conducted.\n\nParticipants completing Part A will be eligible to enroll to the open-label extension (OLE), Part B, if they did not have significant noncompliance with study drug, visits, or procedures, and did not meet any withdrawal criteria. During Part B, the efficacy and safety of INV-202 20 mg daily (pending results of chronic toxicology studies and/or findings from this and other ongoing clinical studies, the alternative dose would be 10 mg) will be further evaluated over an additional 36 weeks, through Week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Male and female participants from 18 to 75 years of age 2. Able and willing to provide informed consent and to comply with scheduled visits and study procedures 3. BMI ≥ 30 kg/m2 4. Presence of at least 3 of the 5 following criteria at screening: i. Increased waist circumference (males, ≥40 inches; females, ≥35 inches) ii. Fasting glucose ≥ 100 mg/dL in the last 3 months or an HgbA1C \\> 5.7% iii. Triglycerides ≥ 150 mg/dL or 1.69 mmol/L iv. HDL \\< 40 mg/dL or 1.03 mmol/L for males or \\< 50 mg/dL or 1.29 mmol/L for females v. Hypertension (systolic \\>130 mmHg and/or diastolic \\> 85 mmHg) or treated for hypertension\n\nExclusion Criteria:\n\n1. Significant medical condition, that in the opinion of the investigator, will place the participant at risk during the study or that will confound the study endpoints\n2. Active substance abuse including inhaled, oral, or injection drugs in the past 12 months\n3. Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening\n4. Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study\n5. History of significant liver disease or evidence of moderate to severe hepatic impairment\n6. History of epilepsy or intracranial surgery\n7. Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary)\n8. Bariatric surgery, use of a GLP-1 agonists or other weight-loss drug, or significant weight change (\\> 5 kg or 11 pounds) in the past 3 months\n9. Participants taking any drug that may be used for weight loss (eg, liraglutide, semaglutide, tirzepatide, orlistat sibutramine phenylpropanolamine , mazindol , phentermine alone or in combination with topiramate, lorcaserin , naltrexone in combination with bupropion)\n10. Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded)\n11. Participants with an active diagnosis or history of a significant psychiatric disorder, including but not limited to the following:\n\n Major depression within the last 2 years\n * Any history of a suicide attempt or suicidal ideation\n * A history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)\n * Taking any of the following medications: antidepressants, atypical antipsychotics and mood stabilizers such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium\n12. Score on the 9-question Patient Health Questionnaire (PHQ-9) of\n13. Current or active malignancy within the past 5 years, except for cancer in situ, or nonmelanoma skin cancer, such as basal cell or squamous cell carcinoma that has been completely resected\n14. A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection\n15. QTc \\> 500 ms at baseline\n16. Any chronic medications with effects on blood pressure, lipids, or blood glucose started or changed within the past 3 months or at risk of requiring a change during the study\n17. Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6, or 2C19 by screening; these medications are prohibited during the entire duration of the study\n18. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit\n19. Previous use of INV-202\n20. Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment'}, 'identificationModule': {'nctId': 'NCT05891834', 'briefTitle': 'Study of INV-202 in Patients With Obesity and Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'INV-CL-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose', 'description': 'INV-202, 10 mg', 'interventionNames': ['Drug: INV-202']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': 'INV-202, 50 mg', 'interventionNames': ['Drug: INV-202']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Matching size and number of tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Middle Dose', 'description': 'INV-202, 20 mg', 'interventionNames': ['Drug: INV-202']}], 'interventions': [{'name': 'INV-202', 'type': 'DRUG', 'description': 'tablet, once daily, oral', 'armGroupLabels': ['High dose', 'Low dose', 'Middle Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablet, once daily, oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3L 3W5', 'city': 'New Westminster', 'state': 'British Colombia', 'country': 'Canada', 'facility': 'Office of David H. Shu, MD', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'B4N 3R7', 'city': 'New Minas', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Centricity Research -New Minas', 'geoPoint': {'lat': 45.0691, 'lon': -64.46958}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Aggarwal and Associates, Limited', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L8L 5G8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Wharton Medical Clinic (WMC) - Toronto', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Milestone Research Inc', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L1J 2K9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centricity Research - Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bluewater Clinical Research Group Inc', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'M3J 0K2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Phase Onward Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Anil K. Gupta Medicine Professional Corporation', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Sameh Fikry Medicine Professional Corporation', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N2T 0C1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Research Solutions', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'G7H 7K9', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ecogene-21', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J6E 2B4', 'city': 'Joliette', 'state': 'Quebec', 'country': 'Canada', 'facility': 'DIEX Research Joliette', 'geoPoint': {'lat': 46.0164, 'lon': -73.4236}}, {'zip': 'G6W OM5', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centricity Research - Levis', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'J7J 2K8', 'city': 'Mirabel', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centricity Research - Mirabel', 'geoPoint': {'lat': 45.65008, 'lon': -74.08251}}, {'zip': 'H4N 2W2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': '9109-0126 Quebec Inc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 4S3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centricity Research - Pointe-Claire', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1N 4V3', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'DIEX Research Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre des maladies lipidique deq Quebec, CMLQ Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G2J 0C4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Alpha Recherche Clinique - Lebourgneuf', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G3K 2P8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Alpha Recherche Clinique Val-Bélair', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1L 0H8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Diex Recherche Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'N5W 6A2', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Diex Recherche Trois-Rivieres', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'G6P 6P6', 'city': 'Victoriaville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Diex Recherche Victoriaville', 'geoPoint': {'lat': 46.05007, 'lon': -71.96579}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inversago Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}