A Safety Study of LY3526318 in Healthy Participants

NCT04682119 | Completed Phase 1 Results

• 3 other identifiers: 178072020-004290-46J2D-MC-CVAC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

  Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

  Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

• Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

  Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

  Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

• Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318

  Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318

  Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

• Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

  Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

  Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

Secondary Outcomes (5)

• Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Single oral dose to up to 11 days of follow-up

• Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 14 days following first dose

• Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)

  Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

• Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)

  Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

• Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)

  Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Study Arms (4)

LY3526318 (Part A)

EXPERIMENTAL

250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition.

Drug: LY3526318

LY3526318 (Part B)

EXPERIMENTAL

250 mg LY3526318 administered orally as multiple doses under fasted or fed condition.

Drug: LY3526318

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally under fasted or fed condition.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered orally under fasted or fed condition.

Drug: Placebo

Interventions

LY3526318 DRUG

Administered orally.

LY3526318 (Part A); LY3526318 (Part B)

Placebo DRUG

Administered orally.

Placebo (Part A); Placebo (Part B)

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 males or females, as determined through medical history and physical examination
• Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
• Have clinical laboratory test results within normal reference range

You may not qualify if:

• Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• Have a history of clinically significant multiple or severe drug allergies
• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
• Have an abnormal blood pressure
• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
• Are unwilling to stop herbal supplements, over the counter or prescription medicines
• Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Participants with a history of drug abuse

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

PRA Health Sciences

Groningen, 9728, Netherlands

Location

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: December 22, 2020
• First Posted: December 23, 2020
• Study Start: December 29, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)