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BYM338/kg · 1 trial · 1 indication
Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.
| Arm | Type | Description |
|---|---|---|
| BYM338 10 mg/kg | EXPERIMENTAL | Bimagrumab (BYM338) 10 mg/kg up to maximum 1200 mg, every 4 weeks until week 44 (12 doses) |
| Placebo | PLACEBO_COMPARATOR | Placebo, every 4 weeks until week 44 (12 doses) |
| Name | Type | Description |
|---|---|---|
| BYM338 10 mg/kg | DRUG | intravenous infusion every four weeks |
| Placebo | OTHER | intravenous infusion every four weeks |
Inclusion Criteria: * Type 2 diabetes with HbA1c between 6.5% and 10% at screening with stable treatment for 3 months prior to randomization * On one of the following anti-diabetes regimens with stable treatment for approximately 3 months prior to randomization: 1) metformin monotherapy; 2) DPP4 in...
BYM338 is an investigational drug being studied for conditions involving skeletal muscle, including sporadic inclusion body myositis, sarcopenia, and chronic obstructive pulmonary disease (COPD) with cachexia. It has also been investigated in type 2 diabetes mellitus. BYM338 is in Phase 2 clinical development and is not approved by the FDA.
BYM338 is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 2 clinical trials for multiple muscle-related conditions, including sarcopenia and COPD with cachexia.
BYM338 is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval.
BYM338 has completed several Phase 2 trials, including NCT01601600 in sarcopenic adults, NCT01669174 in COPD patients with cachexia, NCT02333331 in sarcopenia, and NCT02468674, a 24-week off-drug extension study in sarcopenic elderly. All trials are completed.
BYM338 is also known as bimagrumab. The drug is being studied under the name bimagrumab in clinical trials for sarcopenia and other muscle-wasting conditions. Both names refer to the same investigational compound developed by Novartis.