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OpenTrials
Terminated

NCT Number: NCT07030868

A Study of LY3549492 in Adults 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 evaluate the effects of treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.

Participation in the study will last about 11 months.

Why the study stopped: Study terminated for strategic business reasons
Terminated

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

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, Buenos Aires F.D., 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-GN02:

  • Assigned male at birth
  • Assigned female at birth, who are of non-childbearing potential
  • Have type 2 diabetes

W8M-MC-CWMM:

  • Have a BMI ≥27 kilograms per square meter (kg/m²)
  • Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss

Exclusion criteria

W8M-MC-GN02:

  • Individuals who are of childbearing potential
  • Have a history of acute or chronic pancreatitis
  • 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.

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 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 32

    Percent change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and percent change was to be calculated relative to baseline.

Secondary outcomes

  1. Change From Baseline in Body Weight

    Time frame: Baseline, Week 32

    Change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and absolute change from baseline was to be calculated.

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

    Time frame: Baseline, Week 32

    Percentage of participants who achieved at least 5% reduction in body weight from baseline to Week 32.

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

    Time frame: Baseline, Week 32

    Percentage of participants who achieved at least 10% reduction in body weight from baseline to Week 32.

  4. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 32

    Change from baseline in hemoglobin A1c (HbA1c) at Week 32. HbA1c was intended to be measured as a percentage and reflects average blood glucose levels over approximately 3 months.

  5. Pharmacokinetics (PK): Average Concentration of LY3549492

    Time frame: Week 0 and Week 24 (6-18 hours post-dose); Weeks 3, 9, 15, and 18 (1-3 hours post-dose); Weeks 6 and 21 (3-6 hours post-dose); Week 12 (1-6 hours post-dose); and Weeks 30 and 32 (pre-dose).

    Average plasma concentration of LY3549492. Pharmacokinetic samples were intended to be collected at multiple timepoints, including pre-dose and post-dose intervals, to evaluate the pharmacokinetic profile of LY3549492 over time.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With Type-2 Diabetes (T2D)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Aug 31, 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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