A Study of LY3463251 in Healthy Participants

Healthy Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03764774
• Other study ID #: 17110
• Secondary ID: J1D-MC-GZAA
• Status: Terminated
• Phase: Phase 1
• Start date: December 6, 2018
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 118
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males and females

Exclusion Criteria:

• Diagnosed with Type 1 or Type 2 diabetes
• Women who are of childbearing potential or who are breastfeeding
• Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
• Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3463251
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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 follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
Secondary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251	PK: Cmax of LY3463251	Baseline to Day 29 (Part A); Baseline to Day 107 (Part B)
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251	PK: AUC of LY3463251	Baseline to Day 29 (Part A); Baseline to Day 107(Part B)
Secondary	Pharmacodynamics (PD): AUC of glucose	PD: AUC of glucose	Baseline to Day 85 (Part B)
Secondary	Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline, Day 85 (Part B)