REGN4461 for Metabolic Syndrome

National Institute of Health, Bethesda, MD
Metabolic Syndrome+1 More ConditionsREGN4461 - Drug
Eligibility
18+
All Sexes

Study 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.

Eligible Conditions
  • Metabolic Syndrome
  • Familial Partial Lipodystrophy

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 17 Secondary · Reporting Duration: Week 12 to week 24

Baseline to week 12
Absolute change in HbA1c
Absolute change in hemoglobin A1c (HbA1c)
Change in fasting glucose
Percent change in fasting serum triglyceride (TG)
Percent change in liver fat (MRI-PDFF)
Percent change in liver fat (MRI-PDFF) REGN4461 versus placebo
Percent change in liver fat (MRI-PDFF) placebo
Percent change in liver fat magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) REGN4461
Baseline to week 24
Change on the daily lipodystrophy hunger questionnaire
Percent change in fasting serum TG
Up to week 40
Concentrations of REGN4461 in serum over time
Immunogenicity of REGN4461 over time compared to placebo
Incidence and severity of treatment-emergent adverse events (TEAEs)
Week 24
Body Weight Changes
Percent change in fasting serum TG after the first 12 weeks of exposure to REGN4461
Week 24
Change in HbA1c from baseline to week 12 compared to change between week 12 and week 24
Change in fasting glucose from baseline to week 12 compared to change between week 12 and week 24
Percent change in fasting serum TG from baseline to week 12 compared to the percent change between week 12 and week 24
Percent change in liver fat (MRI-PDFF) from baseline to week 12 compared to percent change between week 12 and week 24

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Study Arm 2
1 of 2
Study Arm 1
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: REGN4461 · Has Placebo Group · Phase 2

Study Arm 2
Drug
Experimental Group · 1 Intervention: REGN4461 · Intervention Types: Drug
Study Arm 1Experimental Group · 2 Interventions: Matching Placebo, REGN4461 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching Placebo
2019
Completed Phase 4
~10750
Mibavademab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 to week 24

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
562 Previous Clinical Trials
356,012 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
235 Previous Clinical Trials
243,539 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.