LEPR Agonist REGN4461 for Familial Partial Lipodystrophy
(LEAP Trial)
Recruiting at9 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Regeneron Pharmaceuticals
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests REGN4461, a medication for managing high blood sugar and fat levels, in patients with low to moderate leptin levels. The treatment aims to improve how the body processes these substances, possibly reducing liver fat and hunger.
Research Team
CT
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Eligibility Criteria
Adults with familial partial lipodystrophy (FPLD) who have stable body weight and diet, and specific metabolic issues related to glucose and triglycerides. They must not be pregnant or breastfeeding, treated with metreleptin recently, or diagnosed with generalized or acquired lipodystrophy.Inclusion Criteria
Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol
I have been diagnosed with familial partial lipodystrophy.
See 3 more
Exclusion Criteria
Pregnant or breastfeeding women
I have not taken metreleptin in the last 3 months.
I have been diagnosed with acquired lipodystrophy.
See 1 more
Treatment Details
Interventions
- REGN4461 (Monoclonal Antibodies)
Trial OverviewThe trial is testing REGN4461, a LEPR agonist antibody for FPLD patients. It's checking if the drug lowers fasting triglycerides in those with high levels and improves blood sugar control in those with high HbA1c. Patients are split into two groups based on their leptin levels.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Study Arm 2Experimental Treatment1 Intervention
Randomized to receive REGN4461 for 24 weeks
Group II: Study Arm 1Experimental Treatment2 Interventions
Randomized to placebo for 12 weeks and then crossover to REGN4461 for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School