Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-13 @ 11:47 PM
Study NCT ID:
NCT06643728
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults 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'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}], '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': 'C000596367', 'term': 'bimagrumab'}, {'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 24'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Percentage of Participants Achieving ≥5% Body Weight Reduction', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Percentage of Participants Achieving ≥10% Body Weight Reduction', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Percentage of Participants Achieving ≥15% Body Weight Reduction', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Change from Baseline in Waist-to-Height Ratio (WHtR)', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Percent Change from Baseline in Visceral Adipose Tissue (VAT)', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Percent Change from Baseline in Total Body Lean Mass by DXA', 'timeFrame': 'Baseline, Week 24, Week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle', 'Lean', 'Fat'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/546217', 'label': 'A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a BMI of\n\n * ≥30 kilograms per square meter (kg/m2) or\n * ≥27 kg/m2 and \\<30 kg/m2, with at least one of the following weight-related comorbidities:\n\n * Hypertension\n * Dyslipidemia\n * Cardiovascular disease\n * Obstructive sleep apnea\n* Have had a stable body weight for the 3 months prior to randomization (\\<5% body weight gain and/or loss)\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity\n* Have at least one laboratory value suggestive of diabetes during screening\n* Use of metformin, or any other glucose-lowering medications\n* Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma\n* Have poorly controlled hypertension\n* Have any of the following cardiovascular conditions within 3 months prior to screening:\n\n * acute myocardial infarction\n * cerebrovascular accident (stroke)\n * unstable angina, or\n * hospitalization due to congestive heart failure\n* Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes\n* Have ongoing or a history of bradyarrhythmias other than sinus bradycardia\n* Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure\n* Have a history of symptomatic gallbladder disease within the past 2 years\n* Have signs and symptoms of any liver disease\n* Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality\n* Have a history of acute or chronic pancreatitis\n* Have renal impairment, measured as estimated glomerular filtration rate \\<30 mL/minute/1.73 m2\n* Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT06643728', 'briefTitle': 'A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': '27265'}, 'secondaryIdInfos': [{'id': 'J4Z-MC-GIDF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Bimagrumab Dose 2 + Tirzepatide Placebo', 'description': 'Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A: Bimagrumab Placebo + Tirzepatide Dose 1', 'description': 'Participants will receive bimagrumab placebo SC and tirzepatide SC', 'interventionNames': ['Drug: Tirzepatide', 'Drug: Bimagrumab Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A: Bimagrumab Placebo + Tirzepatide Dose 2', 'description': 'Participants will receive bimagrumab placebo SC and tirzepatide SC', 'interventionNames': ['Drug: Tirzepatide', 'Drug: Bimagrumab Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Bimagrumab Placebo + Tirzepatide Placebo', 'description': 'Participants will receive bimagrumab placebo SC and tirzepatide placebo SC', 'interventionNames': ['Drug: Bimagrumab Placebo', 'Drug: Tirzepatide Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1', 'description': 'Participants will receive bimagrumab SC and tirzepatide SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Bimagrumab Dose 1 + Tirzepatide Placebo', 'description': 'Participants will receive bimagrumab SC and tirzepatide placebo SC', 'interventionNames': ['Drug: Bimagrumab', 'Drug: Tirzepatide Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Bimagrumab Placebo + Tirzepatide Placebo', 'description': 'Participants will receive bimagrumab placebo SC and tirzepatide placebo SC', 'interventionNames': ['Drug: Bimagrumab Placebo', 'Drug: Tirzepatide Placebo']}], 'interventions': [{'name': 'Bimagrumab', 'type': 'DRUG', 'otherNames': ['LY3985863', 'BYM338', 'VER201'], 'description': 'Administered SC', 'armGroupLabels': ['Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1', 'Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2', 'Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2', 'Part A: Bimagrumab Dose 2 + Tirzepatide Placebo', 'Part B: Bimagrumab Dose 1 + Tirzepatide Placebo', 'Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1', 'Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1', 'Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1', 'Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2', 'Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2', 'Part A: Bimagrumab Placebo + Tirzepatide Dose 1', 'Part A: Bimagrumab Placebo + Tirzepatide Dose 2', 'Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1', 'Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1', 'Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1']}, {'name': 'Bimagrumab Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: Bimagrumab Placebo + Tirzepatide Dose 1', 'Part A: Bimagrumab Placebo + Tirzepatide Dose 2', 'Part A: Bimagrumab Placebo + Tirzepatide Placebo', 'Part B: Bimagrumab Placebo + Tirzepatide Placebo']}, {'name': 'Tirzepatide Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: Bimagrumab Dose 2 + Tirzepatide Placebo', 'Part A: Bimagrumab Placebo + Tirzepatide Placebo', 'Part B: Bimagrumab Dose 1 + Tirzepatide Placebo', 'Part B: Bimagrumab Placebo + Tirzepatide Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc. dba CNS Healthcare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Research', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials - Ravenswood', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'country': 'United States', 'facility': 'SKY Integrative Medical Center/SKYCRNG', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '19462', 'city': 'Plymouth Meeting', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Keystone Clinical Studies', 'geoPoint': {'lat': 40.10233, 'lon': -75.27435}}, {'zip': '98052', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastside Research Associates', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], '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': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}