A Study of LY3502970 in Healthy Male Participants

NCT04680767 | Completed Phase 1 FDA Drug

• 3 other identifiers: 17784J2A-MC-GZGF2020-003160-60
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  Predose up to Day 17 after administration of study drug

• Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  Predose up to Day 17 after administration of study drug

Secondary Outcomes (5)

• Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970

  Predose up to Day 17 after administration of study drug

• Plasma PK: Maximum Concentration (Cmax) of LY3502970

  Predose up to Day 17 after administration of study drug

• Plasma and Whole Blood PK of Radioactivity: AUC

  Predose up to Day 17 after administration of study drug

• Plasma and Whole Blood PK of Radioactivity: Cmax

  Predose up to Day 17 after administration of study drug

• Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine

  Predose up to Day 17 after administration of study drug

Study Arms (1)

[¹⁴C]-LY3502970

EXPERIMENTAL

A single dose of LY3502970 and \[¹⁴C\]-LY3502970 administered orally.

Drug: LY3502970; Drug: [¹⁴C]-LY3502970

Interventions

LY3502970 DRUG

Administered orally.

[¹⁴C]-LY3502970

[¹⁴C]-LY3502970 DRUG

Administered orally.

[¹⁴C]-LY3502970

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are overtly healthy males
• Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive)

You may not qualify if:

• Females
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data
• Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening
• Have evidence of significant active neuropsychiatric disease, as determined by the investigator
• Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications
• Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in
• Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen
• Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research

Leeds, LS2 9LH, United Kingdom

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 23, 2020
• Study Start: March 29, 2021
• Primary Completion: July 3, 2021
• Study Completion: July 3, 2021
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)