What side effects are associated with this type of intervention?

Common treatments for Metabolic Syndrome include lifestyle changes, medications like metformin, statins, and antihypertensives, and newer agents such as GLP-1 receptor agonists. For treatments similar to leptin analogs or modulators like REGN4461, potential side effects may include injection site reactions, nausea, headache, and potential immunogenicity. Broader treatments for Metabolic Syndrome can also cause gastrointestinal issues, muscle pain, and increased risk of hypoglycemia, depending on the specific medication used.

What prior FDA approvals exist?

The FDA has approved several treatments for components of Metabolic Syndrome, such as type 2 diabetes and dyslipidemia, but there are limited approvals specifically for leptin analogs or modulators. Drugs like GLP-1 receptor agonists (e.g., liraglutide and semaglutide) are approved for type 2 diabetes and obesity, which are key components of Metabolic Syndrome. These drugs help improve glycemic control and promote weight loss. While leptin analogs like metreleptin have been approved for generalized lipodystrophy, their use in Metabolic Syndrome is not yet established. REGN4461, a leptin receptor agonist, is currently under investigation and may offer a new therapeutic approach if proven effective.

What other types of research exist?

Promising novel alternatives to REGN4461 for metabolic syndrome patients include: <ol> <li>Liraglutide (GLP-1 receptor agonist) - shown to reduce food intake and improve glycemic control.</li> <li></li> </ol> Tirzepatide (dual GIP and GLP-1 receptor agonist) - demonstrated significant weight loss and improved glycemic outcomes. 3. Anamorelin (ghrelin receptor agonist) - potential for improving appetite and metabolic parameters. 4. AZP-531 (unacylated ghrelin analog) - designed to improve glycemic control and reduce weight.

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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

Must not have

Treatment with metreleptin within 3 months of the screening visit

Patients with a diagnosis of acquired lipodystrophy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 to week 24

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not taken metreleptin in the last 3 months.

Select...

I have been diagnosed with acquired lipodystrophy.

Select...

I have been diagnosed with generalized lipodystrophy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 to week 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in hemoglobin A1c (HbA1c)

Percent change in fasting serum triglyceride (TG)

Secondary study objectives

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

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

2018

Completed Phase 1

~120

Matching Placebo

2012

Completed Phase 4

~10710

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Metabolic Syndrome is commonly treated with lifestyle modifications, medications for managing blood glucose, lipids, and blood pressure, and sometimes weight-loss drugs. Treatments similar to REGN4461, such as leptin analogs or modulators, work by targeting the leptin receptor to regulate appetite and energy balance, which can help reduce body weight and improve insulin sensitivity. This is crucial for Metabolic Syndrome patients as it addresses core issues like obesity and insulin resistance, thereby reducing the risk of type 2 diabetes and cardiovascular diseases.

Neurobiology.