Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-01 @ 1:13 PM
Study NCT ID:
NCT07281495
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taldefgrobep Alfa in Adults With Overweight and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, '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': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in total body weight from Baseline to Week 24', 'timeFrame': 'Baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Percent change in total body fat mass from Baseline to Week 24', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Percent change in total body lean mass from Baseline to Week 24', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities', 'timeFrame': 'Through week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myostatin', 'activin'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the efficacy, safety, and tolerability of taldefgrobep alfa in adults with overweight and obesity, with an open-label extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. a. BMI \\> 30 kg/m2 and BMI \\< 42 kg/m2, OR b. BMI ≥ 27 kg/m2 and BMI \\<30 kg/m2 with at least one weight-related co-morbidity\n2. History of at least one self-reported unsuccessful dietary effort to lose body weight.\n3. Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.\n4. All participants must adhere to protocol contraception requirements\n\nKey Exclusion Criteria:\n\n1. History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening\n2. Non-ambulatory participants, defined as unable to take at least 10 steps independently.\n3. Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.\n4. Participation in another investigational clinical trial while participating in this clinical trial'}, 'identificationModule': {'nctId': 'NCT07281495', 'briefTitle': 'Taldefgrobep Alfa in Adults With Overweight and Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With Open-Label Extension to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Taldefgrobep Alfa in Adults Living With Overweight and Obesity', 'orgStudyIdInfo': {'id': 'BHV2000-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taldefgrobep Alpha once weekly', 'interventionNames': ['Drug: Taldefgrobep Alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo once weekly', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Taldefgrobep Alpha once every 4 weeks', 'interventionNames': ['Drug: Taldefgrobep Alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo once every 4 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Taldefgrobep Alfa', 'type': 'DRUG', 'otherNames': ['BHV-2000'], 'description': 'Subcutaneous injection administered once each week', 'armGroupLabels': ['Taldefgrobep Alpha once weekly']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection (matching placebo) administered once each week', 'armGroupLabels': ['Placebo once weekly']}, {'name': 'Taldefgrobep Alfa', 'type': 'DRUG', 'otherNames': ['BHV-2000'], 'description': 'Subcutaneous injection administered once every 4 weeks', 'armGroupLabels': ['Taldefgrobep Alpha once every 4 weeks']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection (matching placebo) administered once every 4 weeks', 'armGroupLabels': ['Placebo once every 4 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-001', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-011', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33461', 'city': 'Palm Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-008', 'geoPoint': {'lat': 26.6359, 'lon': -80.09615}}, {'zip': '60625', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-007', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-016', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-009', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-006', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-003', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-002', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-005', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75069', 'city': 'McKinney', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-012', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-013', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site-004', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'centralContacts': [{'name': 'Chief Medical Officer', 'role': 'CONTACT', 'email': 'clinicaltrials@biohavenpharma.com', 'phone': '203-404-0410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biohaven Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}