A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants

NCT ID: NCT06890611

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2025-09-26

Brief Summary

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The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.

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

NONE

Study Groups

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Bimagrumab Dose 1 Reference Material

Participants will receive a single dose of bimagrumab subcutaneously (SC)

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)

Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)

Participants will receive a single dose of bimagrumab with tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab + Tirzepatide Coformulation

Intervention Type DRUG

Administered SC

Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)

Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)

Participants will receive bimagrumab with tirzepatide SC for 4 weeks

Group Type EXPERIMENTAL

Bimagrumab + Tirzepatide Coformulation

Intervention Type DRUG

Administered SC

Interventions

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Bimagrumab

Administered SC

Intervention Type DRUG

Tirzepatide

Administered SC

Intervention Type DRUG

Bimagrumab + Tirzepatide Coformulation

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3985863 BYM338 VER201 LY3298176 LY900042

Eligibility Criteria

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Inclusion Criteria

* Are considered healthy as determined by medical evaluation including medical history and physical examination
* Have a body mass index (BMI) within the range of 22.0 to 30.0 kilograms per square meter (kg/m2), inclusive

Exclusion Criteria

* Have current or a history of pancreatitis or hepatitis
* Have a self-reported increase or decrease in body weight, greater than 5 kilograms (kg), within 3 months prior to screening
* Have uncontrolled high blood pressure
* Have taken medications or alternative remedies to promote weight loss within 3 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Fortrea Clinical Research Unit

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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J4Z-MC-GIDG

Identifier Type: OTHER

Identifier Source: secondary_id

27286

Identifier Type: -

Identifier Source: org_study_id

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