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

Eli Lilly and Company125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

125

Conditions

Healthy

Interventions

BimagrumabDRUG

Administered SC

TirzepatideDRUG

Administered SC

Bimagrumab + Tirzepatide CoformulationDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material

Time frame: Predose through Week 13

PK: Cmax of Bimagrumab Reference Material

Time frame: Predose through Week 13

PK: Cmax of Bimagrumab Coadministered with Tirzepatide

Time frame: Predose through Week 13

PK: Cmax of Tirzepatide Coadministered with Bimagrumab

Time frame: Predose through Week 16

PK: Cmax of Bimagrumab Coformulated with Tirzepatide

Time frame: Predose through Week 16

PK: Cmax of Tirzepatide Coformulated with Bimagrumab

Time frame: Predose through Week 16

PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material

Time frame: Predose through Week 13

PK: AUC(0-∞) of Bimagrumab Reference Material

Time frame: Predose through Week 13

PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide

Time frame: Predose through Week 13

PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab

Time frame: Predose through Week 16

PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide

Time frame: Predose through Week 16

PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab

Data from ClinicalTrials.gov

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