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

Completed · Phase 2 · NCT04159415

Conditions: Generalized Lipodystrophy

At a glance

Research payments reported, 2025
$56,787
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
16

About the trial

Sponsor
Regeneron Pharmaceuticals
Tested
Placebo (drug), Low-Dose REGN4461 (drug), High-dose REGN4461 (drug)
Dates
Started 2020-01-07; completion 2024-09-24
Results posted
Yes

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 …

From ClinicalTrials.gov, last updated 2026-06-15. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Regeneron Pharmaceuticals, Inc. reported $56,787 in research payments for this study in 2025 (5 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.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.