Status:
COMPLETED
A Study of LY3493269 in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- 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 venous access sufficient to allow blood sampling as per the protocol.
Exclusion
- 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
- 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 clinical signs or symptoms of liver disease, acute or chronic hepatitis
- Have evidence of significant active neuropsychiatric disease as determined by the investigator
- Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
- 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
- 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 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
- Show evidence of HIV infection and/or positive human HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
- 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
- Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04682106
Start Date
May 3 2021
End Date
November 11 2021
Last Update
January 14 2025
Active Locations (1)
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1
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623