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

Description

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.

Conditions

Obesity, Overweight

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Chandler

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa, Chandler, Arizona, United States, 85225

Phoenix

Hope Research Institute, Phoenix, Arizona, United States, 85018

Scottsdale

Headlands Research - Scottsdale, Scottsdale, Arizona, United States, 85260

Tucson

The Institute for Liver Health II dba Arizona Liver Health-Tucson, Tucson, Arizona, United States, 85712

Greenbrae

NorCal Medical Research, Inc, Greenbrae, California, United States, 94904

Huntington Park

Velocity Clinical Research, Huntington Park, Huntington Park, California, United States, 90255

Rolling Hills Estates

Peninsula Research Associates, Rolling Hills Estates, California, United States, 90274

Walnut Creek

Diablo Clinical Research, Inc. Loc. 4, Walnut Creek, California, United States, 94598

Stamford

Stamford Therapeutics Consortium, Stamford, Connecticut, United States, 06905

Fleming Island

Northeast Research Institute (NERI), Fleming Island, Florida, United States, 32003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)
  • * 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
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-08