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

Phase 2 Interventional Eli Lilly and Company · NCT06603571

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

PhasePhase 2
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations52 sites (Chandler, Arizona and 51 other locations)
Trial IDNCT06603571 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

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions ObesityOverweightType 2 Diabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.