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Monoclonal Antibodies

LEPR Agonist REGN4461 for Familial Partial Lipodystrophy (LEAP Trial)

Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 24
Awards & highlights

LEAP Trial Summary

This trial is studying the effects of a drug called REGN4461 on patients with either high leptin levels or high triglyceride levels. The primary objectives are to evaluate the effect of REGN4461 on fasting triglycerides and hyperglycemia in patients with elevated baseline levels of these markers. Secondary objectives include evaluating the effect of REGN4461 on liver fat, hunger, and safety.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, changes in appetite or hunger sensations, potential liver fat alterations, general discomforts like fatigue or headaches, as well as any immune response to the medication.

LEAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with familial partial lipodystrophy.

LEAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change in hemoglobin A1c (HbA1c)
Percent change in fasting serum triglyceride (TG)
Secondary outcome measures
Absolute change in HbA1c
Body Weight Changes
Change in HbA1c from baseline to week 12 compared to change between week 12 and week 24
+14 more

LEAP Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REGN4461
2022
Completed Phase 2
~140
Matching Placebo
2012
Completed Phase 4
~10710

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
624 Previous Clinical Trials
381,653 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
264 Previous Clinical Trials
252,186 Total Patients Enrolled

Media Library

REGN4461 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05088460 — Phase 2
Metabolic Syndrome Research Study Groups: Study Arm 1, Study Arm 2
Metabolic Syndrome Clinical Trial 2023: REGN4461 Highlights & Side Effects. Trial Name: NCT05088460 — Phase 2
REGN4461 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088460 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this particular research endeavor ever been attempted before?

"Research into the efficacy of REGN4461 commenced in 2020 and was sponsored by Regeneron Pharmaceuticals. After a successful Phase 1 trial involving 16 participants, it achieved its second phase drug approval. Currently, 2 clinical trials are active spanning 6 nations and 5 cities."

Answered by AI

Are there any openings available for volunteers to join this research project?

"Affirmative. Clinicaltrials.gov's data reveals that the experiment, created on February 28th 2022, is now welcoming participants. 40 volunteers must signed up at the 4 designated clinical trial sites."

Answered by AI

What is the underlying aim of this clinical research?

"Regeneron Pharmaceuticals, the sponsor of this trial has set forth a Baseline to week 12 period where the main outcome measure is Absolute alteration in Hemoglobin A1c (HbA1c). Additionally, other secondary objectives include Percent transformation in fasting serum TG distinguished by Cohorts A and B separately and Cohorts A+B in Study Arm 2; Change in HbA1c classified as Cohorts A and B separately and Cohorts A+B located within Study Arm 1; provided patients meet criteria for stability; plus change detected between baseline at week 12 compared to difference from week 12 until week 24 divided as per Cohort"

Answered by AI

In what areas is this trial accessible?

"University of Michigan in Ann Arbor, National Institute of Health in Bethesda, and UT Southwestern Medical Center in Dallas are 3 sites that are permitting patient recruitment for this clinical trial. Additionally, 4 other medical centres have been authorized to enroll participants."

Answered by AI

How large of a cohort is included in this investigation?

"In order for this trial to be successful, 40 volunteers who meet the inclusion criteria must come forward. This can originate from either University of Michigan in Ann Arbor, Michigan or National Institute of Health in Bethesda, Maryland."

Answered by AI

Are there any potential hazards associated with REGN4461 treatments?

"Based on prior data, the safety profile of REGN4461 is placed at 2 due to its status in Phase 2 and lack of evidence for efficacy."

Answered by AI

What former investigations have been undertaken with regards to REGN 4461?

"Currently, two studies are ongoing to study the effects of REGN4461 with 0 trials in stage 3. Most research sites for this compound are located in Pittsburgh, Pennsylvania; however 15 clinical trial locations exist worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
2022. "A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05088460.
~6 spots leftby May 2025
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