REGN4461 for Generalized Lipodystrophy

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

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.

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

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

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.

I have HIV or tested positive for HIV.

I haven't been in a study for a new treatment within the last 3 months.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Group I: Treatment BExperimental Treatment3 Interventions

Group II: Treatment AExperimental Treatment3 Interventions