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
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT06603571
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
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)
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3841136 Dose 2 + Tirzepatide Dose 2 LY3841136 Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 3 + Tirzepatide Dose 3 LY3841136 Participants will receive LY3841136 SC and Tirzepatide SC Tirzepatide Dose 3 Tirzepatide Participants will receive Tirzepatide SC LY3841136 Dose 2 + Tirzepatide Dose 3 LY3841136 Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 2 + Tirzepatide Dose 3 Tirzepatide Participants will receive LY3841136 SC and Tirzepatide SC Placebo Placebo Participants will receive placebo administered SC. LY3841136 Dose 1 LY3841136 Participants will receive LY3841136 subcutaneously (SC) LY3841136 Dose 2 LY3841136 Participants will receive LY3841136 SC LY3841136 Dose 3 LY3841136 Participants will receive LY3841136 SC LY3841136 Dose 1 + Tirzepatide Dose 1 LY3841136 Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 1 + Tirzepatide Dose 1 Tirzepatide Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 2 + Tirzepatide Dose 1 LY3841136 Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 2 + Tirzepatide Dose 1 Tirzepatide Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 3 + Tirzepatide Dose 3 Tirzepatide Participants will receive LY3841136 SC and Tirzepatide SC LY3841136 Dose 2 + Tirzepatide Dose 2 Tirzepatide Participants will receive LY3841136 SC and Tirzepatide SC
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 48
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight Baseline, Week 48 Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 48 Percentage of Participants Who Achieve ≥10% Body Weight Reduction Week 48 Change from baseline in Hemoglobin A1c (HbA1c) Baseline, Week 48 Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136 Baseline, Week 48 PK: Maximum Concentration (Cmax) of LY3841136 Baseline, Week 48
Trial Locations
- Locations (51)
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, 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
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
HOPE Research Institute
🇺🇸Phoenix, Arizona, 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
🇺🇸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