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Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Sponsor: Regeneron Pharmaceuticals
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
Conditions
Interventions
Placebo
Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).
Low-Dose REGN4461
IV infusion loading dose or SC injection QW.
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)