Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 1:06 PM
Study NCT ID:
NCT06972459
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Mexico']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729680', 'term': 'orforglipron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 3b'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 72'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Weight Reduction of ≥5%', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Percent Change from Baseline in Triglycerides', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline up to 72 weeks'}, {'measure': 'Change from Baseline in EQ-5D-5L', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron', 'timeFrame': 'Predose through Week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/609396', 'label': 'A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity (GZPO)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).\n\nParticipation in the study will last about 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:\n\n * hypertension\n * dyslipidemia\n * obstructive sleep apnea, or\n * cardiovascular disease\n* Have a history of at least one unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes\n* Have an unstable body weight within 90 days prior to screening\n* Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening\n* Have acute or chronic hepatitis or pancreatitis\n* Are taking other medications or alternative remedies to manage weight loss'}, 'identificationModule': {'nctId': 'NCT06972459', 'briefTitle': 'A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': '27361'}, 'secondaryIdInfos': [{'id': '2025-521098-14-00', 'type': 'CTIS'}, {'id': 'J2A-MC-GZP1', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'J2A-MC-GZPO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 1', 'description': 'Participants will receive orforglipron orally', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 2', 'description': 'Participants will receive orforglipron orally', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 3', 'description': 'Participants will receive orforglipron orally', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 4', 'description': 'Participants will receive orforglipron orally', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Orforglipron', 'type': 'DRUG', 'otherNames': ['LY3502970'], 'description': 'Administered orally', 'armGroupLabels': ['Orforglipron Dose 1', 'Orforglipron Dose 2', 'Orforglipron Dose 3', 'Orforglipron Dose 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85375', 'city': 'Sun City West', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jalal Abbas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Institute of Arizona (CRI) - Sun City West', 'geoPoint': {'lat': 33.66198, 'lon': -112.34127}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thili Kulatilake', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Novak Clinical Research - Tucson - North La Cholla Boulevard', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yshay Shlesinger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Norcal Endocrinology & Internal Medicine', 'geoPoint': {'lat': 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'country': 'United States', 'contacts': [{'name': 'Michelle Welch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consano Clinical Research, LLC', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '1414', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Hernan Finkelstein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CARE - Centro de Alergia y Enfermedades Respiratorias', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1119ACN', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Angela Romero Zarante', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIPREC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1120AAC', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Diego Aizenberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Médico Viamonte', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, 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