Phase 1
Completed N=16
A Safety Study of LY3526318 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04682119 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 — 147978; 131271; 137814; 76902 nanograms*hours per milliliter (ng*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 |
147978; 131271; 137814; 76902 | — |
| PRIMARY Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 |
12406; 6199; 9544; 5441 | — |
| PRIMARY 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 |
89614 | — |
| PRIMARY Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 |
10717 | — |
| SECONDARY Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
2; 1; 1; 2; 2; 4 | — |
| SECONDARY Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
1; 4; 0; 0 | — |
| SECONDARY Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax) |
1.2768; 0.6195 | — |
| SECONDARY Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) |
1.1341; 0.8454 | — |
| SECONDARY Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) |
0.00; 0.03 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04682119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.