At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 507 enrolled
Drug / intervention
Bimagrumab +2 morebiological
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age 18-80 years
- ✓BMI ≥30 or BMI ≥27 with at least one obesity-associated comorbidity (hypertension, insulin resistance, sleep apnea, dyslipidemia)
- ✓Stable body weight (±5 kg) in past 90 days and body weight <150 kg
- ✓History of at least one unsuccessful behavioral weight-loss attempt
Key exclusion· 6
- ✕Hypersensitivity to monoclonal antibodies or contraindication to semaglutide
- ✕Any investigational drug within 30 days or 5 half-lives of enrollment (whichever longer)
- ✕Obesity medications within 30 days before screening
- ✕Diabetes requiring antidiabetic drugs or HbA1c ≥6.5%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
In Brief
A Phase 2 clinical trial evaluating Bimagrumab, Semaglutide, and 1 other intervention for Obesity and 2 related conditions. Completed, enrolled 507 participants across 26 sites in 3 countries.
Detailed Summary
A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Obese, Overweight or Obesity
CountriesAustralia, New Zealand, United States
CollaboratorsVersanis Bio, Inc.
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartNov 2022
Primary CompletionMay 2024
Study CompletionJun 2025
TodayJul 2026
First PostedNov 14, 2022
Enrollment StartNov 16, 2022
Primary CompletionMay 16, 2024
Study CompletionJun 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.6 years ago
Interventions
Bimagrumabbiological
Human monoclonal antibody to the activin receptor type II
Semaglutidedrug
Glucagon-like peptide-1 (GLP-1) receptor agonist
Placeboother
Placebo