Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06824051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729680', 'term': 'orforglipron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Visceral Adipose Tissue (VAT)', 'timeFrame': 'Baseline, Week 36'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Energy Intake', 'timeFrame': 'Baseline, Week 36'}, {'measure': 'Percent Change from Baseline in Appetite', 'timeFrame': 'Baseline, Week 36'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 36'}, {'measure': 'Percent Change from Baseline in Fasting Total Cholesterol', 'timeFrame': 'Baseline, Week 36'}, {'measure': 'Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)', 'timeFrame': 'Baseline, Week 36'}, {'measure': 'Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores', 'timeFrame': 'Baseline, Week 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visceral adipose tissue', 'Energy intake'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/575755', 'label': 'A Study of Orforglipron (LY3502970) in Adult Participants with Obesity or Overweight'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a Body Mass Index (BMI)\n\n * ≥30.0 kilograms per square meter (kg/m2), or\n * ≥27.0 kg/m2 with comorbidities\n\nExclusion Criteria:\n\n* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma\n* Have an unstable body weight within 90 days prior to screening\n* Have acute or chronic hepatitis\n* Are taking other medications or alternative remedies to manage weight loss'}, 'identificationModule': {'nctId': 'NCT06824051', 'briefTitle': 'A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Double-blind, Two-arm, Mechanism of Action Study to Investigate the Effect of Orforglipron on Body Composition in Adult Participants With Obesity or Overweight, Without Diabetes', 'orgStudyIdInfo': {'id': '27352'}, 'secondaryIdInfos': [{'id': 'J2A-MC-GZPQ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orforglipron', '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']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33172', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '56529', 'city': 'Dilworth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Axis', 'geoPoint': {'lat': 46.87663, 'lon': -96.70341}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Clinical Trials', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}