Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03005288 | Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes | PHASE2 | COMPLETED | 78 | — | — | Feb 1, 2017 | May 8, 2019 | Jan 5, 2021 | 9 | United States, United Kingdom |
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...