A Study of LY3463251 in Healthy Participants

Phase 1TerminatedNCT03764774

Eli Lilly and Company118 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

118

Conditions

Healthy

Interventions

LY3463251DRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Inc

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With One or More Adverse Event(s) (AEs), All Causalities

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

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

Secondary Outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A

PK: Cmax of LY3463251

Time frame: 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

PK: Cmax of LY3463251

Time frame: 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

PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.

Time frame: 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

PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.

Time frame: 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

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.

Data from ClinicalTrials.gov

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