Clinical trial

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

Active, not recruiting · Phase 2 · 2 countries · Registry ID NCT06603571

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

LY3841136

Drug

Administered SC

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Percent Change from Baseline in Body WeightBaseline, Week 48

Study locations

52 locations were listed when this page was built. The first 40 are shown.

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
Centro Médico Viamonte🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL🇦🇷 Buenos Aires, Argentina
Dent Neurologic Institute🇺🇸 Amherst, New York, United States
Medical Research Partners🇺🇸 Ammon, Idaho, United States
IMA Clinical Research Austin🇺🇸 Austin, Texas, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa🇺🇸 Chandler, Arizona, United States
Great Lakes Clinical Trials - Andersonville🇺🇸 Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood🇺🇸 Chicago, Illinois, United States
CTI Clinical Research Center🇺🇸 Cincinnati, Ohio, United States
StudyMetrix Research🇺🇸 City of Saint Peters, Missouri, United States
FutureSearch Trials of Dallas🇺🇸 Dallas, Texas, United States
Velocity Clinical Research, Dallas🇺🇸 Dallas, Texas, United States
Spectrum Medical, Inc.🇺🇸 Danville, Virginia, United States
Velocity Clinical Research, Syracuse🇺🇸 East Syracuse, New York, United States
Northeast Research Institute (NERI)🇺🇸 Fleming Island, Florida, United States
NorCal Medical Research, Inc🇺🇸 Greenbrae, California, United States
Medication Management🇺🇸 Greensboro, North Carolina, United States
Tribe Clinical Research, LLC🇺🇸 Greenville, South Carolina, United States
Indago Research & Health Center, Inc🇺🇸 Hialeah, Florida, United States
PlanIt Research, PLLC🇺🇸 Houston, Texas, United States
Velocity Clinical Research, Huntington Park🇺🇸 Huntington Park, California, United States
Las Vegas Medical Research🇺🇸 Las Vegas, Nevada, United States
New Horizon Research Center🇺🇸 Miami, Florida, United States
Monroe Biomedical Research🇺🇸 Monroe, North Carolina, United States
Lucas Research, Inc🇺🇸 Morehead City, North Carolina, United States
Quality Medical Research🇺🇸 Nashville, Tennessee, United States
Knownwell🇺🇸 Needham, Massachusetts, United States
Lucida Clinical Trials🇺🇸 New Bedford, Massachusetts, United States
Lucas Research, Inc.🇺🇸 New Bern, North Carolina, United States
Suncoast Clinical Research, Inc.🇺🇸 New Port Richey, Florida, United States
Charter Research - Winter Park🇺🇸 Orlando, Florida, United States
HOPE Research Institute🇺🇸 Phoenix, Arizona, United States
North Suffolk Neurology🇺🇸 Port Jefferson Station, New York, United States
Rochester Clinical Research, LLC🇺🇸 Rochester, New York, United States
Peninsula Research Associates🇺🇸 Rolling Hills Estates, California, United States
Endeavor Clinical Trials🇺🇸 San Antonio, Texas, United States
Tekton Research - Fredericksburg Road🇺🇸 San Antonio, Texas, United States
Headlands Research - Scottsdale🇺🇸 Scottsdale, Arizona, United States