Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-04-07 @ 5:57 PM
Study NCT ID:
NCT06345066
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3841136 in Overweight and Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration', 'timeFrame': 'Baseline up to 42 weeks', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline in body weight', 'timeFrame': 'Baseline, Week 42'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136', 'timeFrame': 'Predose up to 42 weeks'}, {'measure': 'Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136', 'timeFrame': 'Predose up to 42 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Body weight'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/471555', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants who are overtly healthy as determined by medical evaluation\n* Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).\n* Have clinical laboratory test results within normal reference range\n* Have venous access sufficient to allow for blood sampling\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n\nExclusion Criteria:\n\n* Have type 1 or type 2 diabetes mellitus\n* Have an abnormal 12-lead electrocardiogram (ECG)\n* Have a history or presence of psychiatric disorders\n* Have abnormal blood pressure and pulse rate\n* Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.'}, 'identificationModule': {'nctId': 'NCT06345066', 'briefTitle': 'A Study of LY3841136 in Overweight and Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants', 'orgStudyIdInfo': {'id': '18834'}, 'secondaryIdInfos': [{'id': 'J3R-MC-YDAC', 'type': 'OTHER', 'domain': 'Eli Lilly And Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3841136 + Tirzepatide', 'description': 'LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.', 'interventionNames': ['Drug: Tirzepatide', 'Drug: LY3841136']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Tirzepatide', 'description': 'Placebo administered SC in combination with tirzepatide given SC.', 'interventionNames': ['Drug: Tirzepatide', 'Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3841136 + Tirzepatide', 'Placebo + Tirzepatide']}, {'name': 'LY3841136', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3841136 + Tirzepatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo + Tirzepatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}