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Clinical Trials in the USA / NCT06603571
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2024-09-20
Last updated
2026-07-17

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

LY3841136TirzepatidePlacebo

LY3841136: Administered SC

Tirzepatide: Administered SC

Placebo: Administered SC

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa Chandler Arizona
HOPE Research Institute Phoenix Arizona
Headlands Research - Scottsdale Scottsdale Arizona
The Institute for Liver Health II dba Arizona Liver Health-Tucson Tucson Arizona
NorCal Medical Research, Inc Greenbrae California
Velocity Clinical Research, Huntington Park Huntington Park California
Peninsula Research Associates Rolling Hills Estates California
Diablo Clinical Research, Inc. Walnut Creek California
Stamford Therapeutics Consortium Stamford Connecticut
Northeast Research Institute (NERI) Fleming Island Florida
Indago Research & Health Center, Inc Hialeah Florida
New Horizon Research Center Miami Florida
Suncoast Clinical Research, Inc. New Port Richey Florida
Charter Research - Winter Park Orlando Florida
Charter Research - Lady Lake The Villages Florida
Medical Research Partners Ammon Idaho
Great Lakes Clinical Trials - Andersonville Chicago Illinois
Great Lakes Clinical Trials - Ravenswood Chicago Illinois
NorthShore University Health System Skokie Illinois
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas
Knownwell Needham Massachusetts
Lucida Clinical Trials New Bedford Massachusetts
Headlands Research - Detroit Southfield Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
StudyMetrix Research City of Saint Peters Missouri
Clinvest Headlands Llc Springfield Missouri
Las Vegas Medical Research Las Vegas Nevada
Dent Neurologic Institute Amherst New York
Velocity Clinical Research, Syracuse East Syracuse New York
North Suffolk Neurology Port Jefferson Station New York
Rochester Clinical Research, LLC Rochester New York
Medication Management Greensboro North Carolina
Monroe Biomedical Research Monroe North Carolina
Lucas Research, Inc Morehead City North Carolina
Lucas Research, Inc. New Bern North Carolina
CTI Clinical Research Center Cincinnati Ohio
Tribe Clinical Research, LLC Greenville South Carolina
Quality Medical Research Nashville Tennessee
IMA Clinical Research Austin Austin Texas

+ 12 more sites — see the full list on the official registry below.

On this site

📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06603571 on ClinicalTrials.gov ↗ ← All trials in the USA