Clinical trial NCT04498390: A Safety Study of LY3493269 in Healthy Participants
Official title: A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 43
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses
timeFrame: Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 2. 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose
measure: PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses
timeFrame: Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: