A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight and Obesity; Obesity

Treatments: Drug: Placebo; Drug: LY3841136

Study type: Interventional

Funder types: Industry

Identifiers

NCT06230523

CWMM Master Protocol (Other Identifier)

W8M-MC-LAA1 (Other Identifier)

18808

Details and patient eligibility

About

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 13 visits.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

W8M-MC-LAA1

• Are males and females who agree to abide by the reproductive and contraceptive requirements

W8M-MC-CWMM:

• BMI ≥30 kilograms per square meter (kg/m²) or

• Have a BMI ≥27 kg/m² and <30 kg/m² with at least one of the following weight-related comorbidities:

  • hypertension: on blood pressure (BP)-lowering medication
  • dyslipidemia: on lipid-lowering medication
  • cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure
  • obstructive sleep apnea

• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

Exclusion criteria

W8M-MC-LAA1

• Have any prior diagnosis of diabetes mellitus except gestational diabetes.

• 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 (CHF).

• Have a history of acute or chronic pancreatitis.

• Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 7 patient groups, including a placebo group

LY3841136 Dose 1

Experimental group

Description:

Participants will receive LY3841136 subcutaneously (SC)

Treatment:

Drug: LY3841136

LY3841136 Dose 2

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

LY3841136 Dose 3

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

LY3841136 Dose 4

Experimental group

Description:

Participants will receive LY3841136 SC.

Treatment:

Drug: LY3841136

LY3841136 Dose 5

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

LY3841136 Dose 6

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

Placebo

Placebo Comparator group

Description:

Participants will receive LY3841136 matching placebo

Treatment:

Drug: Placebo