Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN4461, Low-Dose REGN4461, High-dose REGN4461
mibavademab · 5 trials · 4 indications
Part A
Part A
Part B
Part B
Part B
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
| Arm | Type | Description |
|---|---|---|
| Part A: Arm A | EXPERIMENTAL | - |
| Part A: Arm B | EXPERIMENTAL | - |
| Part A: Arm C | EXPERIMENTAL | - |
| Part A: Arm D | PLACEBO_COMPARATOR | - |
| Part B | EXPERIMENTAL | - |
| Mibavademab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Mibavademab | DRUG | Administered as per the protocol |
| Placebo | DRUG | Administered as per the protocol |
| Low-Dose REGN4461 | DRUG | IV infusion loading dose or SC injection QW. |
| High-dose REGN4461 | DRUG | IV infusion loading dose or SC injection QW. |
Key Inclusion Criteria: 1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines For Part A only: 1. Participants ≥2 years of age at screening 2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screenin...
Mibavademab is an investigational monoclonal antibody developed by Regeneron Pharmaceuticals, Inc. (ticker REGN) for endocrine and metabolic conditions. It is being studied in functional hypothalamic amenorrhea, generalized lipodystrophy, and monogenic obesity. Mibavademab is not approved and remains in clinical development.
Mibavademab targets LEPR, the leptin receptor, and acts as an agonist. By activating this receptor, the antibody is designed to mimic or enhance leptin signaling. Leptin signaling is relevant to energy balance and reproductive hormone regulation, which underlies the conditions being studied.
Mibavademab is being studied for functional hypothalamic amenorrhea, generalized lipodystrophy, and monogenic obesity. These are the indications in its clinical program. It is investigational and has not been approved for any use.
Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN, is developing mibavademab. Regeneron is the sponsor of the clinical trials evaluating the antibody across its endocrine and metabolic indications.
Mibavademab is in Phase 2 and Phase 3 clinical development, depending on the indication. The functional hypothalamic amenorrhea study is Phase 2, while the generalized lipodystrophy and monogenic obesity studies are Phase 3. It is investigational and not FDA approved.
Mibavademab trials include NCT07235917 in functional hypothalamic amenorrhea, NCT07220785 in generalized lipodystrophy, NCT07220772 in monogenic obesity, and NCT06548100, a completed study in generalized lipodystrophy for participants switching from metreleptin. The first three are currently recruiting.