← Back to Search

Monoclonal Antibodies

REGN4461 for Generalized Lipodystrophy

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
Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8, 16 and 24
Awards & highlights

Study Summary

This trial will study the effects of REGN4461 on glycemic parameters and fasting triglyceride levels in patients with diabetes.

Who is the study for?
This trial is for individuals with Generalized Lipodystrophy who have been on a stable diet and medication regimen for at least 3 months. They must have high blood sugar (HbA1c ≥7%) or high fasting triglycerides (TG ≥250 mg/dL). Those with recent weight loss treatments, metreleptin use, uncontrolled hepatitis B/C or tuberculosis, HIV, or participation in other drug trials recently are excluded.Check my eligibility
What is being tested?
The study tests REGN4461's effects on blood sugar control and fasting triglyceride levels in patients with Generalized Lipodystrophy. It compares low-dose and high-dose REGN4461 against a placebo to see how well it works and its impact on insulin sensitivity.See study design
What are the potential side effects?
While the specific side effects of REGN4461 aren't listed here, common ones may include reactions at the injection site, fatigue, headache, potential allergic responses to the antibody treatment, as well as possible impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a rare condition that causes a lack of fat tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8, 16 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8, 16 and 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 from baseline fasting glucose
Absolute change from baseline hemoglobin A1c (HbA1c)
Absolute change from baseline weighted mean glucose (WMG)
+1 more
Secondary outcome measures
Absolute change from baseline in HbA1c over time
Absolute change from baseline in WMG over time
Absolute change from baseline in fasting glucose
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment BExperimental Treatment3 Interventions
Group II: Treatment AExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
624 Previous Clinical Trials
381,657 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
264 Previous Clinical Trials
252,190 Total Patients Enrolled

Media Library

REGN4461 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04159415 — Phase 2
Generalized Lipodystrophy Research Study Groups: Treatment A, Treatment B
Generalized Lipodystrophy Clinical Trial 2023: REGN4461 Highlights & Side Effects. Trial Name: NCT04159415 — Phase 2
REGN4461 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04159415 — Phase 2

Frequently Asked Questions

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

Could you provide a summation of prior research involving Low-Dose REGN4461?

"At present, two Low-Dose REGN4461 trials are taking place and neither of them is in Phase 3. The bulk of these experiments are occurring in Pittsburgh, Pennsylvania but there are 15 trial sites total scattered across the nation."

Answered by AI

Has Low-Dose REGN4461 been authorized by the FDA?

"Though there is data indicating the safety of Low-Dose REGN4461, no clinical trials have yet provided evidence for its efficacy. Therefore, it has been given a score of 2 on our rating scale."

Answered by AI

To what extent is this trial being conducted with participants?

"Sadly, no more participants are being accepted for this clinical trial which was initially posted on July 1st 2020 and last edited on September 19th 2022. If you're still interested in participating in a study, there are presently 19 trials recruiting patients with generalized lipodystrophy and 2 studies looking to enrol those afflicted with Low-Dose REGN4461."

Answered by AI

Has the recruitment period for this experiment opened?

"Clinicaltrials.gov data suggests that this trial has ceased soliciting candidates, with its initial posting on July 1st 2020 and last update occurring on September 19th 2022. Despite the non-recruitment of this specific study, 21 other trials are actively recruiting members currently."

Answered by AI

Does this experiment represent a pioneering endeavor in its field?

"Currently, there are two operational trials for Low-Dose REGN4461 in 5 cities and 6 countries. The original study of this drug was conducted by Regeneron Pharmaceuticals during 2020 and completed its Phase 2 approval process with a sample size of 16 participants. Since then, over 18 thousand studies have been carried out involving the use of this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
2020. "Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04159415.
~3 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top