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NCT Number: NCT06603571

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3841136

Drug

Administered SC

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 48

Secondary outcomes

  1. Change from Baseline in Body Weight

    Time frame: Baseline, Week 48

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame: Week 48

  3. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame: Week 48

  4. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 48

  5. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136

    Time frame: Baseline, Week 48

  6. PK: Maximum Concentration (Cmax) of LY3841136

    Time frame: Baseline, Week 48

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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