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OpenTrials
Completed

NCT Number: NCT06683508

A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa, Chandler, Arizona, United States

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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-GN01:

  • Assigned male at birth
  • Assigned female at birth, who are of non-childbearing potential

W8M-MC-CWMM:

  • Have a BMI of
  • ≥ 30 kilograms per square meter (kg/m²) or
  • ≥ 27 kg/m² and < 30 kg/m² with at least one 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-GN01:

  • Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
  • Have a history of acute or chronic pancreatitis
  • Have renal impairment
  • Individuals who are of childbearing potential

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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
  • Have any of the following cardiovascular conditions within 3 months prior to screening:
  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure.
  • Have a history of symptomatic gallbladder disease within the past 2 years
  • Have a lifetime history of suicide attempts.

Treatment and study plan

LY3549492

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 36

Secondary outcomes

  1. Change from Baseline in Body Weight (kilograms)

    Time frame: Baseline, Week 36

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

    Time frame: Baseline, Week 36

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

    Time frame: Baseline, Week 36

  4. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 36

  5. Pharmacokinetics (PK): Average Concentration of LY3549492

    Time frame: Week 36

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3549492 Once Daily Compared With Placebo in Adult Participants With Obesity or Overweight

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
May 13, 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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