Current partner codePEPTIDESDE
NCT06603571·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

367

Locations

52

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3841136

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Sep 20, 2024

  3. Primary completion

    Jul 1, 2026

  4. Study completion

    Aug 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 48

Secondary outcomes

Change from Baseline in Body Weight

Time frame · Baseline, Week 48

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame · Week 48

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame · Week 48

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline, Week 48

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

Time frame · Baseline, Week 48

PK: Maximum Concentration (Cmax) of LY3841136

Time frame · Baseline, Week 48

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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.

Study locations

52 registered sites.

Argentina · United States. Showing up to 24 locations stored in the fast local snapshot.

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health-Tucson

Tucson, Arizona, United States

NorCal Medical Research, Inc

Greenbrae, California, United States

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Charter Research - Winter Park

Orlando, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Medical Research Partners

Ammon, Idaho, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

NorthShore University Health System

Skokie, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Knownwell

Needham, Massachusetts, United States

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Headlands Research - Detroit

Southfield, Michigan, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.