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

NCT06692348 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27228J2A-JE-GZPM
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

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

  Week 3 Through Week 16

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

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

  Week 3 Through Week 16

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

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

  Week 3 Through Week 16

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

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

  Week 3 Through Week 16

Study Arms (1)

Orforglipron

EXPERIMENTAL

Participants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition.

Drug: Orforglipron

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Orforglipron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Interventions

orforglipron

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: December 13, 2024
• Primary Completion: June 9, 2025
• Study Completion: June 9, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)