A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
- 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.
- Short title
- A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
- Official title
- A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-08-01
- First posted
- 2024-09-19
- Registry last updated
- 2026-07-17
- Primary completion date
- 2026-07-01
- Start date
- 2024-09-20
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06603571
- ClinicalTrials.gov ID
- NCT06603571
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 48
Change from Baseline in Body Weight
Timeframe: Baseline, Week 48
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Timeframe: Week 48
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Timeframe: Week 48
Change from baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136
Timeframe: Baseline, Week 48
PK: Maximum Concentration (Cmax) of LY3841136
Timeframe: Baseline, Week 48
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
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)
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.
- The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United States
- HOPE Research InstitutePhoenix, United States
- Headlands Research - ScottsdaleScottsdale, United States
- The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, United States
- NorCal Medical Research, IncGreenbrae, United States
- Velocity Clinical Research, Huntington ParkHuntington Park, United States
- Peninsula Research AssociatesRolling Hills Estates, United States
- Diablo Clinical Research, Inc.Walnut Creek, United States
- Stamford Therapeutics ConsortiumStamford, United States
- Northeast Research Institute (NERI)Fleming Island, United States
- Indago Research & Health Center, IncHialeah, United States
- New Horizon Research CenterMiami, United States
- Suncoast Clinical Research, Inc.New Port Richey, United States
- Charter Research - Winter ParkOrlando, United States
- Charter Research - Lady LakeThe Villages, United States
- Medical Research PartnersAmmon, United States
- Great Lakes Clinical Trials - AndersonvilleChicago, United States
- Great Lakes Clinical Trials - RavenswoodChicago, United States
- NorthShore University Health SystemSkokie, United States
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
- Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
- KnownwellNeedham, United States
- Lucida Clinical TrialsNew Bedford, United States
- Headlands Research - DetroitSouthfield, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States
And 27 more, listed on the interactive page.
- Related resource (trials.lilly.com)
Other registry identifiers
- W8M-MC-LAA2
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Type 2 diabetes mellitus