NCT04159415

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Lipodystrophy

Interventions

Type	Name	Description
DRUG	Placebo	Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).
DRUG	Low-Dose REGN4461	IV infusion loading dose or SC injection QW.
DRUG	High-dose REGN4461	IV infusion loading dose or SC injection QW.

Timeline

• Start date: 2020-01-07
• Primary completion: 2022-01-05
• Completion: 2024-09-24
• First posted: 2019-11-12
• Last updated: 2025-11-17
• Results posted: 2025-02-25

Locations

8 sites across 4 countries: United States, Peru, Russia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study