A Study of LY3463251 in Healthy Participants

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3463251

• Registration Number: NCT03764774
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2018-12-06
• Status Verified: 2020-12
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Healthy males and females

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Multiple Dose	Placebo	Multiple doses of placebo administered SC
LY3463251 Single dose	LY3463251	Single dose of LY3463251 administered subcutaneously (SC)
Placebo Single dose	Placebo	Single dose of placebo administered SC
LY3463251 Multiple Dose	LY3463251	Multiple doses of LY3463251 administered SC

Primary Outcome Measures

Name	Time	Method
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 follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)	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

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

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States