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REGN4461 · LEAP
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Ensayo de REGENERON PHARMACEUTICALS, INC. en Familial Partial Lipodystrophy · Metabolic Abnormalities (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 20
- Centros
- 8
- Fin del objetivo primario
- dic 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2022.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor Decision».
Qué mide
Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) (del registro, en inglés) (del inicio a la semana 12)
Cómo lo describe el promotor
En el documentoEn inglés, del registroTwo cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: * To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG * To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c) The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia * To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis * To evaluate the effect of REGN4461 on hunger * To evaluate safety and tolerability of REGN4461 * To characterize the concentration profile of REGN4461 over time * To assess immunogenicity to REGN4461
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Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05088460), actualizada en oct 2025.