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A Study of LY3463251 in Healthy Participants

NCT ID: NCT03764774

Last Updated: 2025-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2020-12-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.01 Milligram (mg) LY3463251 Part A Cohort 1

Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

0.03 mg LY3463251 Part A Cohort 2

Single dose of 0.03 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

0.1 mg LY3463251 Part A Cohort 3

Single dose of 0.1 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

0.3 mg LY3463251 Part A Cohort 4

Single dose of 0.3 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

1 mg LY3463251 Part A Cohort 5

Single dose of 1 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

3 mg LY3463251 Part A Cohort 6

Single dose of 3 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

10 mg LY3463251 Part A Cohort 7

Single dose of 10 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

24 mg LY3463251 Part A Cohort 8

Single dose of 24 mg LY3463251 administered SC on Day 1.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

Placebo Single Dose

Single dose of placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3463251

Intervention Type DRUG

Administered SC

Placebo Multiple Dose

Placebo administered SC, QW for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3463251

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Covance Clinical Research Inc

Daytona Beach, Florida, United States

Site Status

Countries

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United States

References

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Benichou O, Coskun T, Gonciarz MD, Garhyan P, Adams AC, Du Y, Dunbar JD, Martin JA, Mather KJ, Pickard RT, Reynolds VL, Robins DA, Zvada SP, Emmerson PJ. Discovery, development, and clinical proof of mechanism of LY3463251, a long-acting GDF15 receptor agonist. Cell Metab. 2023 Feb 7;35(2):274-286.e10. doi: 10.1016/j.cmet.2022.12.011. Epub 2023 Jan 10.

Reference Type DERIVED
PMID: 36630958 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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J1D-MC-GZAA

Identifier Type: OTHER

Identifier Source: secondary_id

17110

Identifier Type: -

Identifier Source: org_study_id

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