Phase 1
Completed N=40
A Safety Study of LY3493269 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04498390 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 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 LY3493269 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 10 weeks and may include 12 visits, including five nights in a row in the clinical research center.
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 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses |
11.7; 39.9; 80.8; 68.2; 17.7; 49.1 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses |
170; 601; 1180; 1080; 302; 868 | — |
Eligibility Criteria
Inclusion Criteria
- Are male or female not of childbearing potential
- Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
- Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
- Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have glycated hemoglobin level of less than ( )450 milliseconds (msec) for males and >470 msec for females, short PR interval ( 220 msec, second and third atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome
- Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
- Have known allergies to LY3493269, related compounds, or any components of the formulation (including C10), or a history of significant atopy
Data sourced from ClinicalTrials.gov (NCT04498390). 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.