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

Lilly

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Eloralintide; Drug: Placebo

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 17 visits.

Enrollment: 263 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:

• Have a body mass index (BMI)

  • ≥30 kilogram/square meter (kg/m²), or
  • ≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity

• 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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263 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.

Treatment:

Drug: Placebo

1 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.

Treatment:

Drug: Eloralintide

3 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 3 mg SC QW for 48 weeks.

Treatment:

Drug: Eloralintide

6 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 6 mg SC QW for 48 weeks.

Treatment:

Drug: Eloralintide

9 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 9 mg SC QW for 48 weeks.

Treatment:

Drug: Eloralintide

6/9 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.

Treatment:

Drug: Eloralintide

3/6/9 mg Eloralintide

Experimental group

Description:

Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.

Treatment:

Drug: Eloralintide