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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Eli Lilly and Company
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Number of Participants With One or More Adverse Event(s) (AEs), All Causalities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
0.01 Milligram (mg) LY3463251 Part A Cohort 1
Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1.
Intervention: LY3463251 (Drug)
0.03 mg LY3463251 Part A Cohort 2
Single dose of 0.03 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
0.1 mg LY3463251 Part A Cohort 3
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
3 mg LY3463251 Part A Cohort 6
Single dose of 3 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
10 mg LY3463251 Part A Cohort 7
Single dose of 10 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
Intervention: LY3463251 (Drug)
Placebo Single Dose
Single dose of placebo administered SC.
Intervention: Placebo (Drug)
1 mg LY3463251 Part B Cohort 1
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.
Intervention: LY3463251 (Drug)
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
Intervention: LY3463251 (Drug)
3/6/9 mg LY3463251 Part B Cohort 3
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.
Intervention: LY3463251 (Drug)
3/9/15/24 mg LY3463251 Part B Cohort
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.
Intervention: LY3463251 (Drug)
Placebo Multiple Dose
Placebo administered SC, QW for 12 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities
Time Frame: 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 Outcomes
- 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: 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: 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: 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)
- Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B(PD: Day -2; Predose: Day 30 and Day 85 (Part B))
- Change From Baseline in Body Weight at Day 85 Part B(Baseline, Day 85 (Part B))