Phase 1
Completed N=65
A Study of LY3522348 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04559568 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0.330; 1.27; 3.37; 9.45; 25.3 | — |
| SECONDARY 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 |
1.76; 5.03; 11.1; 6.00; 14.4; 20.4 | — |
| SECONDARY Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348 |
0.00964; 0.0399; 0.113; 0.323; 0.897 | — |
| SECONDARY Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348 |
0.109; 0.330; 0.690; 0.188; 0.464; 1.15 | — |
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 [ )160/90 millimeters of mercury (mmHg) and pulse rate 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
Data sourced from ClinicalTrials.gov (NCT04559568). 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.