A Multiple-Dose Study of LY3502970 in Healthy Participants

April 30, 2026 updated by: Eli Lilly and Company

A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation.
  • Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Exclusion Criteria:

  • Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
  • Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
  • Participants who 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.
  • Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
  • Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
  • Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3502970 Titration

Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21.

Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD,

Participants were randomized to Fasted state or Fed state sequence on Day 22.
Drug: LY3502970
Administered Orally.
Experimental: LY3502970 (Fasted/Fed)

Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state.

Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state.
Drug: LY3502970
Administered Orally.
Experimental: LY3502970 (Fed/Fasted)

Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state.

Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state.
Drug: LY3502970
Administered Orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time Frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Cmax of LY3502970.
PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970
Time Frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: AUC0-24 of LY3502970.
PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
Time to Maximum Observed Concentration (Tmax) of LY3502970
Time Frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Tmax of LY3502970
PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 15, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18277
  • J2A-MC-GZGJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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