A Study of LY3493269 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682106
• Other study ID #: 17552
• Secondary ID: J1X-MC-GZHF
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2021
• Est. completion date: November 11, 2021

Study information

• Verified date: November 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

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 final follow-up at approximately Day 43
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269	PK: AUC of LY3493269	Baseline through final follow-up at approximately Day 43
Secondary	PK: Maximum Concentration (Cmax) of LY3493269	PK: Cmax of LY3493269	Baseline through final follow-up at approximately Day 43