Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Low-Dose REGN4461, Mibavademab
REGN4461 · 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...
REGN4461 is being developed for the treatment of generalized lipodystrophy, a rare metabolic disorder. It is an investigational monoclonal antibody studied in a Phase 2 clinical trial that enrolled 16 patients with the condition. It has not been approved by the FDA and remains in clinical development.
REGN4461 targets LEPR, the leptin receptor. It is a leptin receptor agonist antibody designed to activate LEPR signaling. By targeting this receptor, the drug aims to address metabolic abnormalities associated with generalized lipodystrophy, where leptin signaling is impaired.
REGN4461 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating the antibody in generalized lipodystrophy.
REGN4461 is in Phase 2 development. A Phase 2 trial in generalized lipodystrophy has been completed. The drug is investigational and has not received FDA approval.
REGN4461 has been studied in one clinical trial, NCT04159415, titled "Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy." This completed Phase 2 trial enrolled 16 patients across the United States, Peru, Russia, and Turkey, and was randomized, double-blind, and controlled.
Yes, Low-Dose REGN4461 is an alternative name for REGN4461. Both refer to the same monoclonal antibody developed by Regeneron Pharmaceuticals for generalized lipodystrophy.