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OpenTrials
Completed

NCT Number: NCT06824051

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight

The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Miami, Florida, 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

  • Have a Body Mass Index (BMI)
  • ≥30.0 kilograms per square meter (kg/m2), or
  • ≥27.0 kg/m2 with comorbidities

Exclusion criteria

  • Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have an unstable body weight within 90 days prior to screening
  • Have acute or chronic hepatitis
  • Are taking other medications or alternative remedies to manage weight loss

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Change from Baseline in Visceral Adipose Tissue (VAT)

    Time frame: Baseline, Week 36

Secondary outcomes

  1. Percent Change from Baseline in Energy Intake

    Time frame: Baseline, Week 36

  2. Percent Change from Baseline in Appetite

    Time frame: Baseline, Week 36

  3. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 36

  4. Percent Change from Baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 36

  5. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline, Week 36

  6. Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores

    Time frame: Baseline, Week 36

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Double-blind, Two-arm, Mechanism of Action Study to Investigate the Effect of Orforglipron on Body Composition in Adult Participants With Obesity or Overweight, Without Diabetes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Feb 25, 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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