A Safety Study of LY3493269 in Healthy Participants

Healthy Clinical Trial

Official title:

A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498390
• Other study ID #: 17451
• Secondary ID: J1X-MC-GZHB
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2020
• Est. completion date: December 28, 2020

Study information

• Verified date: January 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3493269
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 43
Secondary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269	PK: Cmax of LY3493269	Days 1 and 3: Predose through 24 hours post-dose
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3493269	PK: AUC of LY3493269	Days 1 and 3: Predose through 24 hours post-dose