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OpenTrials
Completed

NCT Number: NCT06692348

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
  • Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not 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 study and are willing to follow study procedures

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 other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious 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 serum lipase 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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Primary outcomes

  1. Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)

    Time frame: Week 3 Through Week 16

    PK: Steady-state AUC of Orforglipron (Fasted State)

  2. PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)

    Time frame: Week 3 Through Week 16

    PK: Steady-state Cmax of Orforglipron (Fasted State)

  3. PK: Steady-state AUC of Orforglipron (Fed State)

    Time frame: Week 3 Through Week 16

    PK: Steady-state AUC of Orforglipron (Fed State)

  4. PK: Steady-state Cmax of Orforglipron (Fed State)

    Time frame: Week 3 Through Week 16

    PK: Steady-state Cmax of Orforglipron (Fed State)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Jun 24, 2025

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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