NCT06085482

Brief Summary

The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 27, 2026

Completed
Last Updated

May 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

October 10, 2023

Results QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Absolute Bioavailability of LY3502970

    Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed \[14C\]-LY3502970 compared to oral dosed LY3502970, using formula: \[AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)\] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.

    Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.

Secondary Outcomes (6)

  • PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma

    0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

  • PK: AUC [0-∞] of [14C]-LY3502970 in Plasma

    0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

  • PK: AUC [0-∞] of LY3502970 in Plasma

    Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

  • PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma

    0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

  • PK: Cmax of [14C]-LY3502970 in Plasma

    0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

  • +1 more secondary outcomes

Study Arms (1)

LY3502970 + [14C]-LY3502970

EXPERIMENTAL

Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 (\[14C\]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.

Drug: LY3502970Drug: [14C]-LY3502970

Interventions

LY3502970DRUG

Administered orally

LY3502970 + [14C]-LY3502970
[14C]-LY3502970DRUG

Administered IV

LY3502970 + [14C]-LY3502970

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy as determined by medical evaluation
  • Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
  • Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study

You may not qualify if:

  • Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
  • Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
  • Participants who regularly use known drugs of abuse or show positive findings on drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

orforglipron

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

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

October 10, 2023

First Posted

October 17, 2023

Study Start

October 19, 2023

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

May 27, 2026

Results First Posted

May 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)