Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low-Dose REGN4461 · 1 trial · 1 indication
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 |
|---|---|---|
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW). |
| 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: * Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol * Presence of one or both of the following metabolic abnormalities at screening: 1. HbA1c ≥ 7% OR 2. Fasting TG ≥250 mg/dL * Generally stable diet (based on patient's recal...
Low-Dose REGN4461 is an investigational drug being studied for generalized lipodystrophy, a rare metabolic condition, and has also been evaluated in healthy volunteers. It is being developed by Regeneron Pharmaceuticals, Inc. (REGN) and is currently in Phase 2 clinical development.
Low-Dose REGN4461 is a leptin receptor agonist antibody, meaning it targets and activates the leptin receptor. This mechanism is relevant to its potential use in generalized lipodystrophy, a condition characterized by fat loss and metabolic abnormalities.
Low-Dose REGN4461 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The drug is currently in Phase 2 clinical trials for generalized lipodystrophy.
Low-Dose REGN4461 is in Phase 2 clinical development for generalized lipodystrophy. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study in healthy volunteers has been completed.
Low-Dose REGN4461 has been studied in two completed trials. NCT03530514 was a Phase 1 study in healthy volunteers with 113 participants in Belgium. NCT04159415 was a Phase 2 study in patients with generalized lipodystrophy, enrolling 16 participants across the United States, Peru, Russia, and Turkey.
Yes, Low-Dose REGN4461 is the same drug as REGN4461. The name 'Low-Dose' refers to the specific dosage being studied, but the active agent is REGN4461, a leptin receptor agonist antibody developed by Regeneron Pharmaceuticals.