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HomeTrials › NCT06603571

Obesity & weight · Phase 2 · Active, not recruiting

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

NCT06603571 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying LY3841136, Tirzepatide, Placebo for obesity, overweight.

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo — diagnosis required
What you'd takeLY3841136, Tirzepatide, Placebo
Study length~20 months overall
Planned participants350
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Arizona

  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler
  • HOPE Research Institute — Phoenix
  • Headlands Research - Scottsdale — Scottsdale
  • The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson

California

  • NorCal Medical Research, Inc — Greenbrae
  • Velocity Clinical Research, Huntington Park — Huntington Park
  • Peninsula Research Associates — Rolling Hills Estates
  • Diablo Clinical Research, Inc. — Walnut Creek

Connecticut

  • Stamford Therapeutics Consortium — Stamford

Florida

  • Northeast Research Institute (NERI) — Fleming Island
  • Indago Research & Health Center, Inc — Hialeah
  • New Horizon Research Center — Miami
  • Suncoast Clinical Research, Inc. — New Port Richey
  • Charter Research - Winter Park — Orlando
  • Charter Research - Lady Lake — The Villages

Idaho

  • Medical Research Partners — Ammon

Illinois

  • Great Lakes Clinical Trials - Andersonville — Chicago
  • Great Lakes Clinical Trials - Ravenswood — Chicago
  • NorthShore University Health System — Skokie

Iowa

  • Iowa Diabetes and Endocrinology Research Center — West Des Moines

Kansas

  • Cotton O'Neil Diabetes & Endocrinology — Topeka

Massachusetts

  • Knownwell — Needham
  • Lucida Clinical Trials — New Bedford

Michigan

  • Headlands Research - Detroit — Southfield
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy

Missouri

  • StudyMetrix Research — City of Saint Peters
  • Clinvest Headlands Llc — Springfield

Nevada

  • Las Vegas Medical Research — Las Vegas

New York

  • Dent Neurologic Institute — Amherst
  • Velocity Clinical Research, Syracuse — East Syracuse
  • North Suffolk Neurology — Port Jefferson Station
  • Rochester Clinical Research, LLC — Rochester

North Carolina

  • Medication Management — Greensboro
  • Monroe Biomedical Research — Monroe
  • Lucas Research, Inc — Morehead City
  • Lucas Research, Inc. — New Bern

Ohio

  • CTI Clinical Research Center — Cincinnati

South Carolina

  • Tribe Clinical Research, LLC — Greenville

Tennessee

  • Quality Medical Research — Nashville

Texas

  • IMA Clinical Research Austin — Austin
  • Velocity Clinical Research, Dallas — Dallas
  • FutureSearch Trials of Dallas — Dallas
  • PlanIt Research, PLLC — Houston
  • Tekton Research - Fredericksburg Road — San Antonio
  • Endeavor Clinical Trials — San Antonio
  • Texas Valley Clinical Research — Weslaco

Virginia

  • Spectrum Medical, Inc. — Danville

Washington

  • Central Washington Health Services Association d/b/a Confluence Health — Wenatchee

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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