Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ActRIIB-IgG1
ACE-031 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| ACE-031 | EXPERIMENTAL | 8 dosing groups |
| Placebo | PLACEBO_COMPARATOR | - |
| single | EXPERIMENTAL | 8 subjects (6 active and 2 placebo) |
| Name | Type | Description |
|---|---|---|
| ACE-031 | BIOLOGICAL | Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months. |
| Placebo | BIOLOGICAL | Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months. |
Inclusion Criteria: * Postmenopausal * Body mass index (BMI) of ≥ 18.5 to \< 32. Exclusion Criteria: * History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas * History of clinically significant cardiac, endocrinologic, he...
ACE-031 is an investigational monoclonal antibody being developed for muscle loss and muscular atrophy. It has been studied in healthy postmenopausal women to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is in Phase 1 clinical development and is not approved for any indication.
ACE-031 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is a monoclonal antibody in Phase 1 clinical development for musculoskeletal conditions such as muscle loss and muscular atrophy.
ACE-031 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both in healthy postmenopausal women, with no active trials currently ongoing.
ACE-031 has been studied in two completed Phase 1 clinical trials: NCT00755638 and NCT00952887. Both trials enrolled healthy postmenopausal women aged 45 years and older in Canada, with a total enrollment of 70 participants across the studies.
ACE-031 is also known as ActRIIB-IgG1, as referenced in the clinical trial titles. The drug is a monoclonal antibody being investigated for muscle loss and muscular atrophy in Phase 1 studies.