DRUG
LY3841136
Administered SC
Status
Active, not recruiting
Phase
Phase 2
Enrollment
367
Locations
52
Results
Not posted
Publications
0
Study summary
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.
Interventions
DRUG
Administered SC
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Sep 19, 2024
Study start
Sep 20, 2024
Primary completion
Jul 1, 2026
Study completion
Aug 2026
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 48
Change from Baseline in Body Weight
Time frame · Baseline, Week 48
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame · Week 48
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame · Week 48
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136
Time frame · Baseline, Week 48
PK: Maximum Concentration (Cmax) of LY3841136
Time frame · Baseline, Week 48
Eligibility
Inclusion Criteria: W8M-MC-LAA2 * Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²) * Have Type 2 Diabetes * Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening W8M-MC-CWMM: * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) Exclusion Criteria: W8M-MC-LAA2 * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Have an on-going or history of bradyarrhythmia and/or sinus bradycardia * Have an elevated resting pulse rate (mean \>100 beats per minute (bpm)) or reduced resting pulse rate (mean \<60 bpm) at screening * Have any of the following cardiovascular conditions within 6 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliters per minute (mL/min)/1.73 m2 * Have a history of acute or chronic pancreatitis * Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening * All concomitant medications should be at a stable dose for at least 3 months prior to screening W8M-MC-CWMM * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * Have poorly controlled hypertension. * Have a history of symptomatic gallbladder disease within the past 2 years * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have a lifetime history of suicide attempts.
Study locations
Argentina · United States. Showing up to 24 locations stored in the fast local snapshot.
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Medical Research Partners
Ammon, Idaho, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Knownwell
Needham, Massachusetts, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Headlands Research - Detroit
Southfield, Michigan, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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