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.
- Metabolic Syndrome
- Familial Partial Lipodystrophy
2 Primary · 17 Secondary · Reporting Duration: Week 12 to week 24
2 Treatment Groups
Study Arm 2
1 of 2
Study Arm 1
1 of 2
40 Total Participants · 2 Treatment Groups
Primary Treatment: REGN4461 · Has Placebo Group · Phase 2
Who is running the clinical trial?
Age 18+ · All Participants · 7 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
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
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
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
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
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
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
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