A Study of Two Different Formulations 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 2 Different Formulations of LY3502970 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
  • Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
  • Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

  • Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening
  • Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
  • Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
  • Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
  • Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. 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, or both. 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, or all. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2 mg/4mg/8mg LY3502970 - Dose Titration Period

Participants received escalating oral doses of LY3502970 according to the following dosing schedule:

  • Days 1-7: 2 milligrams (mg) once daily (QD)
  • Days 8-14: 4 mg QD
  • Days 15-21: 8 mg QD
Drug: LY3502970
Administered orally.
Experimental: 16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period
Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2.
Drug: LY3502970
Administered orally.
Experimental: 16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period
Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2.
Drug: LY3502970
Administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2
Time Frame: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Cmax of LY3502970 in Formulation 1 and Formulation 2
Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
Time Frame: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2
Time Frame: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Tmax of LY3502970 in Formulation 1 and Formulation 2
Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 15, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17785
  • J2A-MC-GZGH (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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