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

February 24, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33172
        • Clinical Pharmacology of Miami
    • Minnesota
      • Dilworth, Minnesota, United States, 56529
        • Axis
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Ohio Clinical Trials
    • Texas
      • San Antonio, Texas, United States, 78240
        • Endeavor Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Visceral Adipose Tissue (VAT)
Time Frame: Baseline, Week 36
Baseline, Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Energy Intake
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Appetite
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Fasting Total Cholesterol
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores
Time Frame: Baseline, Week 36
Baseline, Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Actual)

January 26, 2026

Study Completion (Actual)

January 26, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27352
  • J2A-MC-GZPQ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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