A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
- Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
- Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
- Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
- Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
- No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Treatment with metreleptin within 3 months of the screening visit
- Patients with a diagnosis of generalized lipodystrophy
- Patients with a diagnosis of acquired lipodystrophy
- Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Familial Partial Lipodystrophy,Metabolic Abnormalities
Age (in years)
18+
Phase
Phase 2
Participants needed
40
Est. Completion Date
Jun 27, 2025
Treatment type
Interventional
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov identifier
NCT05088460
Study number
R4461-PLD-20100
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