Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:39 AM
Study NCT ID:
NCT07476118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Body Weight', 'timeFrame': 'Week 1, Week 29'}], 'secondaryOutcomes': [{'measure': 'Number of Participants who discontinued due to an Adverse Events (AEs)', 'timeFrame': 'Day 1 through Week 37'}, {'measure': 'Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs', 'timeFrame': 'Day 1 through Week 37'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide', 'timeFrame': 'Pre-dose on Day 1 through Week 37'}, {'measure': 'PK: Maximum Concentration (Cmax) of Brenipatide', 'timeFrame': 'Pre-dose on Day 1 through Week 37'}, {'measure': 'Percentage of Participants Achieving ≥ 5% Reduction in Body Weight', 'timeFrame': 'Week 29'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Week 1, Week 29'}, {'measure': 'Change in Waist-to-Height Ratio', 'timeFrame': 'Week 1, Week 29'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Week 1, Week 29'}, {'measure': 'Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)', 'timeFrame': 'Week 1, Week 29'}, {'measure': 'Change in High-sensitive C-reactive Protein (hsCRP)', 'timeFrame': 'Week 1, Week 29'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation\n* Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg/m\\^2)\n* Have no significant (not more than 5 percent \\[%\\]) self-reported weight gain or loss in the past 3 months prior to screening\n\nExclusion Criteria:\n\n* Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data\n* Have a prior diagnosis of type 1 or type 2 diabetes mellitus\n* Have a history of acute or chronic pancreatitis\n* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2\n* Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, GIP/GLP-1/glucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening\n* Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal/nutritional supplements), that promote weight loss within 6 months prior to screening\n* Are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT07476118', 'briefTitle': 'A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': '27802'}, 'secondaryIdInfos': [{'id': 'J2S-MC-GZMU', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brenipatide', 'description': 'Participants will receive brenipatide subcutaneously (SC).', 'interventionNames': ['Drug: Brenipatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo administered SC.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Brenipatide', 'type': 'DRUG', 'otherNames': ['LY3537031'], 'description': 'Administered SC.', 'armGroupLabels': ['Brenipatide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117-5116', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '866-429-3700'}, {'name': 'Kathleen Doisy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fortrea Clinical Research Unit - Daytona Beach', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '866-429-3700'}, {'name': 'Gene Voskuhl', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fortrea Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '866-429-3700'}, {'name': 'Kimberly Cruz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fortrea Clinical Research Unit Inc. - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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'}}}}