At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 78 enrolled
Drug / intervention
BYM338 10 mg/kg +1 moredrug
Likely dose
BYM338 (bimagrumab) 10 mg/kg intravenous infusion every 4 weeksAI-extracted
Key inclusion· 4
- ✓Type 2 diabetes with HbA1c between 6.5% and 10% at screening, stable treatment for ≥3 months prior to randomization
- ✓On stable anti-diabetes therapy (metformin monotherapy, DPP4 inhibitor monotherapy, metformin + DPP4 inhibitor combination, or no therapy) for ≥3 months prior to randomization
- ✓Body Mass Index 28-40 kg/m² at screening
- ✓Body weight between 65-140 kg at screening
Key exclusion· 12
- ✕Type 1 diabetes, surgically induced diabetes, brittle Type 2 diabetes, or history of severe hypoglycemic episodes in prior year or hypoglycemic unawareness
- ✕History of clinically significant arrhythmias, heart failure, unstable angina, myocardial infarction, stroke, CABG, PCI, DVT/PE, valve disorders, or pulmonary hypertension within 6 months (1 year for drug-eluting stents)
- ✕Tachycardia
- ✕Use of anti-obesity medications, nutritional supplements, or OTC weight loss products within 3 months of screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Subject- and Investigator-blinded, Placebo Controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of Intravenous Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes
In Brief
A Phase 2 clinical trial evaluating BYM338 10 mg/kg and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 78 participants across 9 sites in 2 countries.
Detailed Summary
This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartFeb 2017
Primary CompletionMar 2019
Study CompletionMay 2019
TodayJul 2026
First PostedDec 29, 2016
Enrollment StartFeb 1, 2017
Primary CompletionMar 21, 2019
Study CompletionMay 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.5 years ago
Interventions
BYM338 10 mg/kgdrug
intravenous infusion every four weeks
Placeboother
intravenous infusion every four weeks