Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 2
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 3
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Active Comparator
Tirzepatide Dose 3
Participants will receive Tirzepatide SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Placebo Comparator
Placebo
Participants will receive placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

More Details

NCT ID
NCT06603571
Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.