Investigating weight management treatments for adults with obesity and type 2 diabetes
A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
This study is testing a new weight management treatment for adults with obesity and type 2 diabetes to see if it helps them lose weight and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 52 sites (Chandler, Arizona and 51 other locations) |
| Trial ID | NCT06603571 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of LY3841136, both alone and in combination with Tirzepatide, for managing weight in adults who are overweight or obese and have type 2 diabetes. Participants will be monitored over a period of approximately 64 weeks to assess changes in weight and other health markers. The study includes a range of doses and compares the active treatments against a placebo. The goal is to determine the best approach for chronic weight management in this population.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 27 kg/m² or higher who have type 2 diabetes and have maintained a stable body weight for the past three months.
Not a fit: Patients with a history of severe hypoglycemia or certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for weight management in patients with obesity and type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using similar approaches for weight management in patients with type 2 diabetes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chandler, Arizona and 51 other locations
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler, Arizona, United States (Recruiting)
- HOPE Research Institute — Phoenix, Arizona, United States (Recruiting)
- Headlands Research - Scottsdale — Scottsdale, Arizona, United States (Recruiting)
- The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson, Arizona, United States (Recruiting)
- NorCal Medical Research, Inc — Greenbrae, California, United States (Recruiting)
- Velocity Clinical Research, Huntington Park — Huntington Park, California, United States (Recruiting)
- Peninsula Research Associates — Rolling Hills Estates, California, United States (Recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Recruiting)
- Stamford Therapeutics Consortium — Stamford, Connecticut, United States (Recruiting)
- Northeast Research Institute (NERI) — Fleming Island, Florida, United States (Recruiting)
- Indago Research & Health Center, Inc — Hialeah, Florida, United States (Recruiting)
- New Horizon Research Center — Miami, Florida, United States (Recruiting)
- Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (Recruiting)
- Charter Research - Winter Park — Orlando, Florida, United States (Recruiting)
- Charter Research - Lady Lake — The Villages, Florida, United States (Recruiting)
- Medical Research Partners — Ammon, Idaho, United States (Recruiting)
- Great Lakes Clinical Trials - Andersonville — Chicago, Illinois, United States (Recruiting)
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (Recruiting)
- NorthShore University Health System — Skokie, Illinois, United States (Recruiting)
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (Recruiting)
- Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States (Recruiting)
- Knownwell — Needham, Massachusetts, United States (Recruiting)
- Lucida Clinical Trials — New Bedford, Massachusetts, United States (Recruiting)
- Headlands Research - Detroit — Southfield, Michigan, United States (Recruiting)
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (Recruiting)
- StudyMetrix Research — Saint Peters, Missouri, United States (Recruiting)
- Clinvest Headlands Llc — Springfield, Missouri, United States (Recruiting)
- Las Vegas Medical Research — Las Vegas, Nevada, United States (Recruiting)
- Dent Neurologic Institute — Amherst, New York, United States (Recruiting)
- Velocity Clinical Research, Syracuse — East Syracuse, New York, United States (Recruiting)
- North Suffolk Neurology — Port Jefferson Station, New York, United States (Recruiting)
- Rochester Clinical Research, LLC — Rochester, New York, United States (Recruiting)
- Medication Management — Greensboro, North Carolina, United States (Recruiting)
- Monroe Biomedical Research — Monroe, North Carolina, United States (Recruiting)
- Lucas Research, Inc — Morehead City, North Carolina, United States (Recruiting)
- Lucas Research, Inc. — New Bern, North Carolina, United States (Recruiting)
- CTI Clinical Research Center — Cincinnati, Ohio, United States (Recruiting)
- Tribe Clinical Research, LLC — Greenville, South Carolina, United States (Recruiting)
- Quality Medical Research — Nashville, Tennessee, United States (Recruiting)
- IMA Clinical Research Austin — Austin, Texas, United States (Recruiting)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (Recruiting)
- FutureSearch Trials of Dallas — Dallas, Texas, United States (Recruiting)
- PlanIt Research, PLLC — Houston, Texas, United States (Recruiting)
- Tekton Research - Fredericksburg Road — San Antonio, Texas, United States (Recruiting)
- Endeavor Clinical Trials — San Antonio, Texas, United States (Recruiting)
- Texas Valley Clinical Research — Weslaco, Texas, United States (Recruiting)
- Spectrum Medical, Inc. — Danville, Virginia, United States (Recruiting)
- Central Washington Health Services Association d/b/a Confluence Health — Wenatchee, Washington, United States (Recruiting)
- Centro Médico Viamonte — Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (Recruiting)
- Consultorio de Investigación Clínica EMO SRL — Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (Recruiting)
+2 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.