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
NCT ID: NCT06603571
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
350 participants
INTERVENTIONAL
2024-09-20
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
LY3841136
Administered SC
LY3841136 Dose 2
Participants will receive LY3841136 SC
LY3841136
Administered SC
LY3841136 Dose 3
Participants will receive LY3841136 SC
LY3841136
Administered SC
LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
Tirzepatide Dose 3
Participants will receive Tirzepatide SC
Tirzepatide
Administered SC
LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
Placebo
Participants will receive placebo administered SC.
Placebo
Administered SC
Interventions
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LY3841136
Administered SC
Tirzepatide
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion 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
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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Clinvest Headlands Llc
Springfield, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Dent Neurologic Institute
Amherst, New York, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States
North Suffolk Neurology
Port Jefferson Station, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Medication Management
Greensboro, North Carolina, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Lucas Research, Inc.
New Bern, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Quality Medical Research
Nashville, Tennessee, United States
IMA Clinical Research Austin
Austin, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, United States
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Centro Médico Viamonte
Buenos Aires, , Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, , Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, , Argentina
Countries
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Related Links
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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
Other Identifiers
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W8M-MC-LAA2
Identifier Type: OTHER
Identifier Source: secondary_id
W8M-MC-CWMM Master Protocol
Identifier Type: OTHER
Identifier Source: secondary_id
18809
Identifier Type: -
Identifier Source: org_study_id
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