A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

June 23, 2025 updated by: Eli Lilly and Company

A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated.

The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

533

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
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research, LLC
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Fortrea Clinical Research Unit
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Altasciences Company Inc.
    • Missouri
      • Springfield, Missouri, United States, 65802
        • QPS
    • Texas
      • Dallas, Texas, United States, 75247
        • Fortrea Clinical Research Unit
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Fortrea Clinical Research Unit

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

Yes

Description

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical history and physical examination.
  • Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
  • Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  • Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

  • Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
  • Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
  • Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
  • Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
  • Have known clinically significant gastric emptying abnormality.
  • Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
  • Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
  • Have an abnormal 12-lead electrocardiogram (ECG) at screening.
  • Have history of pancreatitis.
  • Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
  • Have difficulty swallowing capsules or tablets.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron
Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron
Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
τ is 24 hours for once daily (QD) dosing
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
τ is 24 hours for QD dosing
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)

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)

June 24, 2024

Primary Completion (Actual)

June 2, 2025

Study Completion (Actual)

June 2, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18617
  • J2A-MC-GZPI (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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