Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

Generalized Lipodystrophy Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

Status Active, not recruiting

Clinical Trial Summary

The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL).

The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Generalized Lipodystrophy
• Lipodystrophy

• NCT number: NCT04159415
• Study type: Interventional
• Source: Regeneron Pharmaceuticals
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 7, 2020
• Completion date: October 29, 2024