At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
In Brief
A Phase 2 clinical trial evaluating Placebo, Low-Dose REGN4461, and 1 other intervention for Generalized Lipodystrophy. Completed, enrolled 16 participants across 8 sites in 4 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Interventions
Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).
IV infusion loading dose or SC injection QW.
IV infusion loading dose or SC injection QW.