NCT03492840

Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease

An Open Label, Phase 2a Clinical Trial for the Evaluation of Safety and Efficacy of RZL-012 for the Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Raziel Therapeutics Ltd. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will receive RZL-012.

Detailed description

This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. * The 1st cohort will be comprised of subjects with Dercum's disease. * The 2nd cohort will be comprised of subjects with lipedema with substantial fat above the knee Within each cohort dosing of the subjects will progress consecutively from one individual to the other with a minimum 7 days between subjects to asses safety. The study design will allow the physicians to monitor safety for at least 7 days prior to dosing the next subject. Cohort 2 will be conducted in a dose escalation manner and the decision to proceed to the next dose level will be made after reviewing all safety data collected by Day 14 within 2+/-1 day of the last dosed subject. The trial will proceed within a cohort provided that no more than one subject experience intolerable side effects in a cohort, and based on the decision made by the Principal Investigator (PI) and the medical monitor.

Conditions

• Lipedema
• Dercum Disease

Interventions

Type	Name	Description
DRUG	RZL-012	The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites

Timeline

• Start date: 2018-06-28
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2018-04-10
• Last updated: 2024-02-08
• Results posted: 2024-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study