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

Last updated: June 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Orforglipron

Clinical Study ID

NCT06440980
18617
J2A-MC-GZPI
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical history and physicalexamination.

  • Have a stable body weight for one month prior to screening (less than or equal to 5percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40kilogram per meter square (kg/m²).

  • Participants must be reliable and willing to make themselves available for theduration of the study and are willing to follow study procedures.

  • Have venous access sufficient to allow for blood sampling.

Exclusion

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 othersignificant active, uncontrolled medical conditions.

  • Have significant history of or currently have major depressive disorder orpsychiatric disorder within the last 2 years.

  • Obesity induced by other endocrine disorders, such as Cushing's syndrome orPrader-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 endocrineneoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroidcancer.

  • 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 Design

Total Participants: 533
Treatment Group(s): 1
Primary Treatment: Orforglipron
Phase: 1
Study Start date:
June 24, 2024
Estimated Completion Date:
June 02, 2025

Connect with a study center

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Fortrea CRU, Inc.

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Altasciences Company Inc.

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • QPS

    Springfield, Missouri 65802
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Dallas, Texas 75247
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Madison, Wisconsin 53704
    United States

    Site Not Available

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