A Safety Study of LY3493269 in Healthy Participants
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3493269 LY3493269 administered orally. |
Drug: LY3493269
Administered orally.
|
| Placebo Comparator: Placebo Placebo administered orally. |
Drug: Placebo
Administered orally.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 43]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 [Days 1 and 3: Predose through 24 hours post-dose]
PK: Cmax of LY3493269
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3493269 [Days 1 and 3: Predose through 24 hours post-dose]
PK: AUC of LY3493269
Eligibility Criteria
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 (<)6.5 percent (%)
Exclusion Criteria:
-
Have a supine heart rate (HR) less than 50 beats per minute (bpm) or greater than 100 bpm. If a repeat measurement shows values within the range, the participant can be included in the trial
-
Have a mean supine systolic blood pressure (BP) higher than 160 millimeters of Mercury (mmHg) and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at screening (excluding white-coat hypertension); therefore, if a repeated measurement shows values within the range, the participant can be included in the trial
-
Have undergone any form of bariatric surgery
-
Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
-
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
-
Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN)
-
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
-
Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
-
Have participated within the past 30 days of screening in a clinical study involving an investigational product (IP); at least 5 half-lives or 30 days, whichever is longer, should have passed
-
Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QT interval corrected using Fridericia's formula (QTcF) greater than (>)450 milliseconds (msec) for males and >470 msec for females, short PR interval (<120 msec), or 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lilly Centre for Clinical Pharmacology | Singapore | Singapore | 138623 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17451
- J1X-MC-GZHB