A Study of Two Different Formulations of LY3502970 in Healthy Participants

NCT05341089 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17785J2A-MC-GZGH
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

  PK: Cmax of LY3502970

  Pre-dose on Day 1 up to 39 days post-dose

• PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970

  PK: AUC0-24 of LY3502970

  Pre-dose on Day 1 up to 39 days post-dose

• PK: Time to Maximum Observed Concentration (Tmax) of LY3502970

  PK: Tmax of LY3502970

  Pre-dose on Day 1 up to 39 days post-dose

Study Arms (2)

LY3502970 (Formulation 1)

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

LY3502970 (Formulation 2)

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

LY3502970 (Formulation 1); LY3502970 (Formulation 2)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: May 17, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09-15

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)