Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05869903
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3127}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline to Week 72'}], 'secondaryOutcomes': [{'measure': 'Mean Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Percent Change from Baseline in Fasting non-HDL Cholesterol', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Percent Change from Baseline in Fasting Triglycerides', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Change from Baseline in Hemoglobin A1c (HbA1c) %', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Percent Change from Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Change from Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Mean Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization', 'timeFrame': 'Baseline, Week 176'}, {'measure': 'Time to Onset of Type 2 Diabetes', 'timeFrame': 'Baseline through Week 176, Baseline through Week 190'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight', 'Overweight or Obesity']}, 'referencesModule': {'references': [{'pmid': '40960239', 'type': 'DERIVED', 'citation': 'Wharton S, Aronne LJ, Stefanski A, Alfaris NF, Ciudin A, Yokote K, Halpern B, Shukla AP, Zhou C, Macpherson L, Allen SE, Ahmad NN, Klise SR; ATTAIN-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment. N Engl J Med. 2025 Nov 6;393(18):1796-1806. doi: 10.1056/NEJMoa2511774. Epub 2025 Sep 16.'}], 'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/403875', 'label': 'A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a BMI\n\n * ≥30.0 kilogram/square meter (kg/m²),\n * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:\n\n * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).\n* Have a history of at least 1 self-reported 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, history of ketoacidosis, or hyperosmolar state/coma\n* Have a self-reported change in body weight \\>5 kg (11 pounds) within 90 days prior to screening.\n* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.\n* Have had a history of chronic or acute pancreatitis.'}, 'identificationModule': {'nctId': 'NCT05869903', 'acronym': 'ATTAIN-1', 'briefTitle': 'A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)', 'orgStudyIdInfo': {'id': '18559'}, 'secondaryIdInfos': [{'id': 'J2A-MC-GZGP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2022-502839-19-00', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'U1111-1289-8877', 'type': 'OTHER', 'domain': 'UTN Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 1', 'description': 'Participants will receive orforglipron administered orally.', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 2', 'description': 'Participants will receive orforglipron administered orally.', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Orforglipron Dose 3', 'description': 'Participants will receive orforglipron administered orally.', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be given placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Orforglipron', 'type': 'DRUG', 'otherNames': ['LY3502970'], 'description': 'Administered orally.', 'armGroupLabels': ['Orforglipron Dose 1', 'Orforglipron Dose 2', 'Orforglipron Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health II dba Arizona Clinical Trials - Mesa', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85375', 'city': 'Sun City West', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Institute of Arizona (CRI) - Sun City West', 'geoPoint': {'lat': 33.66198, 'lon': -112.34127}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network Research Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'NorCal Medical Research, Inc', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Westlake', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Norcal Endocrinology & Internal Medicine', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'University Clinical 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