Overview

Bimagrumab has been used in trials studying the treatment and supportive care of Sarcopenia, Skeletal Muscle, Mechanical Ventilation, Sporadic Inclusion Body Myositis, and Sporadic Inclusion Body Myositis (sIBM), among others.

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 28, 2025

Bimagrumab (DB12584): A Comprehensive Report on an Investigational Activin Receptor Type II Inhibitor

Table of Contents

Executive Summary
Introduction to Bimagrumab
Drug Identity, Properties, and Development History

[3.1. Key Identifiers and Basic Properties]
[3.2. Developer History and Strategic Shifts]

Mechanism of Action

[4.1. Molecular Target: Activin Type II Receptors (ActRIIA and ActRIIB)]
[4.2. Downstream Signaling Modulation]

Pharmacodynamics (PD)

[5.1. Effects on Muscle Mass and Composition]
[5.2. Effects on Muscle Strength and Physical Function]
[5.3. Effects on Fat Mass]
[5.4. Effects on Metabolic Parameters]
[5.5. Effects on Bone Metabolism]
[Table: Overview of Bimagrumab Pharmacodynamic Effects in Humans]

Pharmacokinetics (PK)

[6.1. Administration and Bioavailability]
[6.2. Distribution, Metabolism, Elimination, Half-life]
[6.3. Anti-Drug Antibodies (ADAs)]

Clinical Development Program

[7.1. Sporadic Inclusion Body Myositis (sIBM)]
[7.2. Sarcopenia]
[7.3. Obesity and Type 2 Diabetes Mellitus (T2DM)]
[7.4. Other Investigated Indications]
[Table: Summary of Key Bimagrumab Clinical Trials]

Safety and Tolerability Profile

[8.1. Overview from Pooled Analyses and Multiple Studies]
[8.2. Specific Adverse Event Profile in Key Indications]
[8.2.1. Sporadic Inclusion Body Myositis (sIBM)]
[8.2.2. Sarcopenia]
[8.2.3. Obesity and Type 2 Diabetes]
[8.2.4. Healthy Older and Obese Adults (Phase I)]
[8.3. Effects on Pituitary Hormonal Axes]

Regulatory Status

[9.1. FDA Breakthrough Therapy Designation]
[9.2. Orphan Drug Designations]

Discussion and Future Perspectives
Conclusion

1. Executive Summary

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of LY3985863 in Healthy Participants	2025/06/22	NCT07030127	Phase 1	Not yet recruiting	Eli Lilly and Company
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes	2025/03/28	NCT06901349	Phase 2	Active, not recruiting	Eli Lilly and Company
A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants	2025/03/24	NCT06890611	Phase 1	Recruiting	Eli Lilly and Company
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight	2024/10/16	NCT06643728	Phase 2	Recruiting	Eli Lilly and Company
Effect of Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults with Obesity	2023/07/06	NCT05933499	Phase 2	Not yet recruiting	Massachusetts General Hospital
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese	2022/11/14	NCT05616013	Phase 2	Active, not recruiting	Eli Lilly and Company
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203	2015/10/09	NCT02573467	Phase 3	Completed	Novartis Pharmaceuticals
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study	2015/06/11	NCT02468674	Phase 2	Completed	Novartis Pharmaceuticals
Dose Range Finding Study of Bimagrumab in Sarcopenia	2015/01/07	NCT02333331	Phase 2	Completed	Novartis Pharmaceuticals
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery	2014/06/02	NCT02152761	Phase 2	Completed	Novartis Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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