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

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

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
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 48

  1. Change from Baseline in Body Weight

    Timeframe: Baseline, Week 48

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Timeframe: Week 48

  3. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Timeframe: Week 48

  4. Change from baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline, Week 48

  5. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136

    Timeframe: Baseline, Week 48

  6. PK: Maximum Concentration (Cmax) of LY3841136

    Timeframe: Baseline, Week 48

Sources for outcomes

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.
Sources for eligibility

  • 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.

Sources for sites

Other registry identifiers

  • W8M-MC-LAA2
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)