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COMPLETED
NCT04159415
PHASE2

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2020-01-07

Completion Date

2024-09-24

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

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.

Locations (8)

Regeneron Research Site

Bethesda, Maryland, United States

Regeneron Research Site

Ann Arbor, Michigan, United States

Regeneron Research Site

Dallas, Texas, United States

Regeneron Research Site

Piura, Peru

Regeneron Research Site

Moscow, Russia

Regeneron Research Site

Ankara, Turkey (Türkiye)

Regeneron Research Site

Diyarbakır, Turkey (Türkiye)

Regeneron Research Site

Izmir, Turkey (Türkiye)