A Study of LY3522348 in Healthy Participants

NCT04559568 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17808J2U-MC-YBAA
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

  Part A: Baseline up to Day 14; Part B: Baseline up to Day 28

Secondary Outcomes (4)

• Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348

  Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)

• Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348

  Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)

• Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348

  Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)

• Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348

  Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)

Study Arms (11)

Part A: Placebo

PLACEBO COMPARATOR

A single dose of Placebo administered orally on Day 1.

Drug: Placebo

Part A: 5 milligrams (mg) LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part A: 15 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part A: 50 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part A: 150 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part A: 380 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part B: Placebo

PLACEBO COMPARATOR

Placebo administered orally once daily on Days 1-14.

Drug: Placebo

Part B: Placebo + Midazolam

EXPERIMENTAL

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.

Drug: Placebo; Drug: Midazolam

Part B: 50 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part B: 120 mg LY3522348

EXPERIMENTAL

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

Drug: LY3522348

Part B: 290 mg LY3522348 + Midazolam

EXPERIMENTAL

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.

Drug: LY3522348; Drug: Midazolam

Interventions

LY3522348 DRUG

Administered orally.

Part A: 15 mg LY3522348; Part A: 150 mg LY3522348; Part A: 380 mg LY3522348; Part A: 5 milligrams (mg) LY3522348; Part A: 50 mg LY3522348; Part B: 120 mg LY3522348; Part B: 290 mg LY3522348 + Midazolam; Part B: 50 mg LY3522348

Placebo DRUG

Administered orally.

Part A: Placebo; Part B: Placebo; Part B: Placebo + Midazolam

Midazolam DRUG

Administered orally.

Part B: 290 mg LY3522348 + Midazolam; Part B: Placebo + Midazolam

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Related Publications (1)

• 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.

  PMID: 40358849 DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 23, 2020
• Study Start: October 15, 2020
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)