A Randomized Withdrawal Extension Study of multiple Bimagrumab doses in Older Adults With Sarcopenia Previously Participating in the Core Study

A 28 Week Randomized Withdrawal Extension of a Double-blind, Placebo-controlled, Parallel Group Study to Assess Durability of Effect on Skeletal Muscle Strength and Function Upon Withdrawal of Bimagrumab (higer dose level, intermediate dose level, lower dose level) in Older Adults With Sarcopenia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223245

Enrollment

240

Registered

2016-06-17

Start date

2016-03-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Interventions

investigational material(s) Generic name etc : BYM338 INN of investigational material : bimagrumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202).

Exclusion criteria

Exclusion criteria: *Use of prohibited treatments as per recommendations outlined in protocol. *History of severe hypersensitivity reaction in the core study (CBYM338E2202). *History of breaking of the blind (inadvertently or for emergency reasons) in the core study (CBYM338E2202). *History of adverse event(s) in the core study (CBYM338E2202) that in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study. *Clinically significant abnormal liver function tests that would have resulted in discontinuation of study drug while participating in the core study(CBYM338E2202) as per protocol. *Any medical condition or laboratory finding, which, in the opinion of the investigator prevents the subject from continuing participation in the study, may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk to the subject in administering bimagrumab. Other protocol defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy 6 minute walk test [ Time Frame: Week 25, Week 49 ] Change from Week 25 to Week 49	—

Secondary

Measure	Time frame
safety Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: Weeks 25, 29, 37, 45, 49, 53 ] Assessed by various measures such as adverse events over study efficacy Short Physical Performance Battery [ Time Frame: Weeks 33, 41, 49 ] Change from Week 25 to Week 49 efficacy Gait speed [ Time Frame: Weeks 33, 41, 49 ] Change from Week 25 to Week 49 efficacy Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: Weeks 37, 49 ] Change from Week 25 to Week 49	—

Measure

Time frame

safety Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: Weeks 25, 29, 37, 45, 49, 53 ] Assessed by various measures such as adverse events over study efficacy Short Physical Performance Battery [ Time Frame: Weeks 33, 41, 49 ] Change from Week 25 to Week 49 efficacy Gait speed [ Time Frame: Weeks 33, 41, 49 ] Change from Week 25 to Week 49 efficacy Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: Weeks 37, 49 ] Change from Week 25 to Week 49

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026