A Study of LY3463251 in Healthy Participants

Phase 1

Terminated

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

• 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

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
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Results First Submitted: 2025-08-21
• Status Verified: 2025-10
• Results First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Results First Posted: 2025-11-04
• Last Update Posted: 2025-11-04

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.01 Milligram (mg) LY3463251 Part A Cohort 1	LY3463251	Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1.
0.03 mg LY3463251 Part A Cohort 2	LY3463251	Single dose of 0.03 mg LY3463251 administered SC on Day 1.
0.1 mg LY3463251 Part A Cohort 3	LY3463251	Single dose of 0.1 mg LY3463251 administered SC on Day 1.
0.3 mg LY3463251 Part A Cohort 4	LY3463251	Single dose of 0.3 mg LY3463251 administered SC on Day 1.
1 mg LY3463251 Part A Cohort 5	LY3463251	Single dose of 1 mg LY3463251 administered SC on Day 1.
3 mg LY3463251 Part A Cohort 6	LY3463251	Single dose of 3 mg LY3463251 administered SC on Day 1.
10 mg LY3463251 Part A Cohort 7	LY3463251	Single dose of 10 mg LY3463251 administered SC on Day 1.
24 mg LY3463251 Part A Cohort 8	LY3463251	Single dose of 24 mg LY3463251 administered SC on Day 1.
Placebo Single Dose	Placebo	Single dose of placebo administered SC.
1 mg LY3463251 Part B Cohort 1	LY3463251	1 mg LY3463251 administered SC, once weekly (QW) for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
3 mg LY3465231 Part B Cohort 2	LY3463251	3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
3/6/9 mg LY3463251 Part B Cohort 3	LY3463251	3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
3/9/15/24 mg LY3463251 Part B Cohort	LY3463251	3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
Placebo Multiple Dose	Placebo	Placebo administered SC, QW for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities	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 serious adverse events (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 Part A	Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose	PK: Cmax of LY3463251
PK: Maximum Observed Concentration of LY3463251 Part B	Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdose	PK: Cmax of LY3463251
PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A	Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose	PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B	Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdose	PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B	PD: Day -2; Predose: Day 30 and Day 85 (Part B)	AUC of glucose was analyzed using a model with treatment + Day + Treatment\*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure.
Change From Baseline in Body Weight at Day 85 Part B	Baseline, Day 85 (Part B)	Change from Baseline in Body Weight

Trial Locations

Locations (1)

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