REGN4461 for Generalized Lipodystrophy

Recruiting at 7 trial locations

Overseen By Clinical Trials Administrator

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Metreleptin, Weight loss drugs, Glucocorticoids

Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication regimen has been stable for at least 3 months before the screening visit. You should discuss your specific medications with the trial team.

What is the purpose of this trial?

This trial is testing a new medication called REGN4461 to help patients with high blood sugar or high blood fat levels. The medication aims to improve how the body handles sugar and fats, making it easier to control diabetes and reduce heart disease risk.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

My diet and medication for my metabolic disease have been stable for the last 3 months.

I have been diagnosed with a rare condition that causes a lack of fat tissue.

Your blood test results show high levels of HbA1c or fasting TG.

Exclusion Criteria

I do not have active hepatitis B, hepatitis C, or tuberculosis.

I have not taken metreleptin in the last month.

I have not taken more than 7.5 mg of steroids daily in the last 3 months and don't plan to during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN4461 to evaluate its effects on glycemic parameters and fasting triglyceride levels

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 120 weeks

Treatment Details

Interventions

• REGN4461

Trial Overview 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.

Participant Groups

Group I: Treatment B Experimental Treatment 3 Interventions

Group II: Treatment A Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School