3 completed, 3 recruiting, 1 available, 1 terminated. 3 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 1, Recruiting 1, Terminated 1 |
| Phase 3 | 3 | Recruiting 2, Completed 1 |
| Phase 1 | 1 | Completed 1 |
Follow REGN4461: new trials by email Literature Review of REGN4461 trials Research Report on REGN4461
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy Mibavademab, Placebo - Generalized Lipodystrophy | Phase 3 | Recruiting | Regeneron Pharmaceuticals | 28 | 2026-03-13 | 2026-10-23 |
| A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea Mibavademab, Placebo - Functional Hypothalamic Amenorrhea, FHA | Phase 2 | Recruiting | Regeneron Pharmaceuticals | 34 | 2026-03-11 | 2026-10-01 |
| A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults Mibavademab - Monogenic Obesity | Phase 3 | Recruiting | Regeneron Pharmaceuticals | 4 | 2026-02-09 | 2026-10-22 |
| A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD) mibavademab - Generalized Lipodystrophy | Phase 3 | Completed | Regeneron Pharmaceuticals | 9 | 2024-12-16 | 2026-07-29 |
| A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity Tirzepatide, Mibavademab, Tirzepatide-Placebo - Obesity | Phase 2 | Completed | Eli Lilly and Company | 392 | 2024-04-24 | 2026-05-06 |
| A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) REGN4461, Matching Placebo - Familial Partial Lipodystrophy, Metabolic Abnormalities | Phase 2 | Terminated | Regeneron Pharmaceuticals | 20 | 2022-02-28 | 2025-10-16 |
| A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers REGN4461, Placebo - Healthy Volunteers | Phase 1 | Completed | Regeneron Pharmaceuticals | 113 | 2018-04-24 | 2020-03-09 |
| Compassionate Use or Expanded Access of Mibavademab REGN4461 - Lipodystrophy, Generalized Lipodystrophy (GLD) | Available | Regeneron Pharmaceuticals | 2026-10-27 |
Lipodystrophy, Congenital Generalized (3) · Lipodystrophy, Familial Partial (3) · Obesity, Morbid (2) · Amenorrhea (1) · Diabetes Mellitus (1) · Hypertriglyceridemia (1) · Infertility, Female (1) · Insulin Resistance (1) · Lipodystrophy (1) · Obesity (1)
Regeneron Pharmaceuticals (7) · Eli Lilly and Company (1)
United States (5) · France (2) · Turkey (Türkiye) (2) · Belgium (1) · Brazil (1) · Germany (1) · Spain (1)
2018 (1)