A Study of LY3493269 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04682106
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
6.3
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants
Actual Study Start Date :
May 3, 2021
Actual Primary Completion Date :
Nov 11, 2021
Actual Study Completion Date :
Nov 11, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3493269

Multiple doses of LY3493269 administered orally.

Drug: LY3493269
Administered orally.

Placebo Comparator: Placebo

Placebo administered orally.

Drug: Placebo
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through final follow-up at approximately Day 43]

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269 [Baseline through final follow-up at approximately Day 43]

    PK: AUC of LY3493269

  2. PK: Maximum Concentration (Cmax) of LY3493269 [Baseline through final follow-up at approximately Day 43]

    PK: Cmax of LY3493269

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Lilly Centre for Clinical PharmacologySingaporeSingapore138623

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04682106
Other Study ID Numbers:
  • 17552
  • J1X-MC-GZHF
First Posted:
Dec 23, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Nov 19, 2021