A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

Orforglipron

Clinical Study ID

NCT06692348
27228
J2A-JE-GZPM
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a stable body weight, that is, less than a 5% body weight change, for 1 monthprior to randomization and body mass index (BMI) within the range 23.0 to 35.0kilogram per square meter (kg/m²), inclusive

  • Have safety laboratory test results within normal reference range for the populationor investigative site, or results with acceptable deviations that are judged to benot clinically significant by the investigator

  • Have venous access sufficient to allow for blood sampling

  • Are reliable and willing to make themselves available for the duration of the studyand are willing to follow study procedures

Exclusion

Exclusion Criteria:

  • Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%

  • Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)

  • Have a history of significant active or unstable major depressive disorder or othersevere psychiatric disorder, for example, schizophrenia, bipolar disorder, or otherserious mood or anxiety disorder within the 2 years prior to screening

  • Actively suicidal and therefore deemed to be at significant risk for suicide

  • Have a known clinically significant gastric emptying abnormality

  • Have history or presence of acute or chronic pancreatitis or an elevation in serumlipase or amylase levels greater than 3 times the upper limit of normal (ULN)

  • Have an abnormal blood pressure (BP), pulse rate, or both

  • Have difficulty swallowing capsules

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Orforglipron
Phase: 1
Study Start date:
December 13, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka-shi, Osaka 532-0003
    Japan

    Site Not Available

  • Sumida Hospital

    Sumida-ku, Tokyo 130-0004
    Japan

    Site Not Available

  • Hakata Clinic

    Fukuoka, 812-0025
    Japan

    Site Not Available

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