A Study of Two Different Formulations of LY3502970 in Healthy Participants

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2	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	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	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

• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 15, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: orforglipron
• Other Study ID 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