A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Familial Partial Lipodystrophy, Metabolic Abnormalities
In brief
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 hypertriglyceridemia * To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B: * To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis * To evaluate the effect of REGN4461 on hunger * To evaluate safety and tolerability of REGN4461 * To characterize the concentration profile of REGN4461 over time * To assess immunogenicity to REGN4461
Key facts
- Study ID
- NCT05088460
- Run by
- Regeneron Pharmaceuticals
- People needed
- 20
- Starts
- 2022-02-28
- Expected to finish
- 2024-04-18
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Excel Medical Clinical Trials - A Flourish Research Site — Boca Raton, Florida, United States
- National Institute of Health — Bethesda, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- ICAN, Institute of Cardiometabolism and Nutrition — Paris, France
- Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo — Santiago de Compostela, Galicia, Spain
- Ege University Faculty of Medicine — Izmir, Bornova, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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