A Study of LY3522348 in Healthy Participants

NCT ID: NCT04559568

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-08-17

Brief Summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A: Placebo

A single dose of Placebo administered orally on Day 1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Part A: 5 milligrams (mg) LY3522348

A single dose of 5 mg LY3522348 administered orally on Day 1.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part A: 15 mg LY3522348

A single dose of 15 mg LY3522348 administered orally on Day 1.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part A: 50 mg LY3522348

A single dose of 50 mg LY3522348 administered orally on Day 1.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part A: 150 mg LY3522348

A single dose of 150 mg LY3522348 administered orally on Day 1.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part A: 380 mg LY3522348

A single dose of 380 mg LY3522348 administered orally on Day 1.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part B: Placebo

Placebo administered orally once daily on Days 1-14.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Part B: Placebo + Midazolam

Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Administered orally.

Midazolam

Intervention Type: DRUG

Administered orally.

Part B: 50 mg LY3522348

50 mg LY3522348 administered orally once daily on Days 1-14.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part B: 120 mg LY3522348

120 mg LY3522348 administered orally once daily on Days 1-14.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Part B: 290 mg LY3522348 + Midazolam

290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.

Group Type: EXPERIMENTAL

LY3522348

Intervention Type: DRUG

Administered orally.

Midazolam

Intervention Type: DRUG

Administered orally.

Interventions

LY3522348

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Midazolam

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy as determined through medical evaluation including medical history and physical examination
• Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
• Have had a stable weight for one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
• Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria

• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
• Have blood pressure of greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
• Have a history of fructosuria
• Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Covance Clinical Research Inc

Daytona Beach, Florida, United States

Countries

United States

References

Fukuda T, Thompson BR, Brouwers B, Qian HR, Wang W, Morse BL, LaBell ES, Durham TB, Konig M, Haupt A, Benson CT, MacKrell J. LY3522348, A New Ketohexokinase Inhibitor: A First-in-Human Study in Healthy Adults. Diabetes Ther. 2025 Jul;16(7):1399-1415. doi: 10.1007/s13300-025-01752-5. Epub 2025 May 13.

Reference Type: DERIVED

PMID: 40358849 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2U-MC-YBAA

Identifier Type: OTHER

Identifier Source: secondary_id

17808

Identifier Type: -

Identifier Source: org_study_id