Clinical trial NCT04682106: A Study of LY3493269 in Healthy Participants
Official title: A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-23
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: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening


Eligibility criteria: Inclusion Criteria:

1. Are male or female not of childbearing potential
2. Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
3. Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
4. 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
5. Have venous access sufficient to allow blood sampling as per the protocol.

Exclusion Criteria:

1. Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data
2. Have undergone any form of bariatric surgery
3. Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
4. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
5. 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)
6. Have clinical signs or symptoms of liver disease, acute or chronic hepatitis
7. Have evidence of significant active neuropsychiatric disease as determined by the investigator
8. Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
9. Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
10. 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
11. 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 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
12. Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times (X) ULN or total bilirubin level (TBL) \>1.5X ULN
13. Show evidence of HIV infection and/or positive human HIV antibodies
14. Show evidence of hepatitis C and/or positive hepatitis C antibody
15. Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
16. Have donated blood of more than 450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 3 calendar months
17. Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy

Primary outcomes:
measure: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
timeFrame: Baseline through Day 44
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269
timeFrame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
measure: PK: Maximum Concentration (Cmax) of LY3493269
timeFrame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post 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: