A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

About the trial

Sponsor

Regeneron Pharmaceuticals

Tested

REGN4461 (drug), Matching Placebo (drug)

Dates

Started 2022-02-28; completion 2024-04-18

Results posted

Yes

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: * To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG * To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c) The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on fasting TG levels in patients with hyp…

From ClinicalTrials.gov, last updated 2025-10-16. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Regeneron Pharmaceuticals, Inc. reported $134,764 in research payments for this study in 2025 (148 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.