Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN4461 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: Single dose cohort 1 | EXPERIMENTAL | Cohort 1 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 2 | EXPERIMENTAL | Cohort 2 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 3 | EXPERIMENTAL | Cohort 3 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 4 | EXPERIMENTAL | Cohort 4 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 5 | EXPERIMENTAL | Cohort 5 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 6 | EXPERIMENTAL | Cohort 6 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 7 | EXPERIMENTAL | Cohort 7 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 8 | EXPERIMENTAL | Cohort 8 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 9 | EXPERIMENTAL | Cohort 9 will receive a single IV dose of REGN4461 or matching placebo |
| Part B: Repeated dose cohort 10 | EXPERIMENTAL | Cohort 10 will receive repeated IV or SC doses of REGN4461 or matching placebo |
| Name | Type | Description |
|---|---|---|
| REGN4461 | DRUG | REGN4461 |
| Placebo | DRUG | Placebo-matching REGN4461 |
Key Inclusion Criteria Part A: * Males and females 18 to 50 years of age, inclusive * Body mass index (BMI) from 18.5 to \<30.0 kg/m\^2 * Participant is judged by the investigator to be in good health and free from major comorbidities based on medical history, physical examination, laboratory safe...
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.