Phase 2
N=160
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT02468674 ↗Enrolled (actual)
160
Serious AEs
3.1%
Results posted
Dec 2019
Primary outcome: Primary: Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 — 8.8; 10.2; 8.0; 8.0 Scores on a scale — p=0.759
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimagrumab (Drug); Placebo (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 |
8.8; 10.2; 8.0; 8.0; 9.5; 7.5 | 0.759 |
| PRIMARY Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 |
8.6; 8.8 | 0.839 |
| SECONDARY Population I: 6-minute Walking Distance (6MWT) at Week 49 |
318.2; 354.1; 304.1; 361.5; 316.1; 273.4 | 0.669 |
| SECONDARY Population II: 6-minute Walking Distance (6MWT) at Week 49 |
321.2; 323.1 | 0.367 |
| SECONDARY Population I: Gait Speed at Week 49 |
0.8; 1.0; 0.9; 1.1; 0.9; 0.7 | 0.875 |
| SECONDARY Population II: Gait Speed at Week 49 |
0.9; 0.9 | 0.395 |
| SECONDARY Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 |
6.6; 6.0; 6.1; 5.8; 5.9; 5.2 | 0.120 |
| SECONDARY Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 |
5.6; 5.5 | 1.000 |
| SECONDARY Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 |
41.4; 34.0; 35.5; 32.6; 34.9; 34.0 | 0.084 |
| SECONDARY Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 |
34.9; 33.7 | 1.000 |
Summary
This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.
Eligibility Criteria
Inclusion criterion:
- 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 criterion:
- Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)
Data sourced from ClinicalTrials.gov (NCT02468674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.