A Safety Study of LY3493269 in Healthy Participants

NCT ID: NCT04498390

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2020-12-28

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3493269

8, 24 or 48 milligrams (mg) LY3493269 + 250 or 500 mg permeation enhancer sodium caprate(C10) Once daily (QD) administered orally over 3 consecutive study days.

Group Type: EXPERIMENTAL

LY3493269

Intervention Type: DRUG

Administered orally.

Placebo

Placebo administered orally over 3 consecutive study days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

LY3493269

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

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 (<)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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J1X-MC-GZHB

Identifier Type: OTHER

Identifier Source: secondary_id

17451

Identifier Type: -

Identifier Source: org_study_id