Lipedema Clinical Trial
Official title:
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
This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee or women and men with nodular Dercum's disease. Each cohort will have 6 subjects who will receive RZL-012.
This is an open label, 2 cohort clinical trial in women with lipedema with substantial fat
above the knee or women and men with nodular Dercum's disease. Each cohort will have 6
subjects who will receive RZL-012.
- 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 of 7-days between subjects to assess safety. This 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 ±
1d of the last dosed subject. The trial will proceed within a cohort provided that no more
than one subject experiences intolerable side effects in a cohort, and based on the decision
made by the Principal Investigator (PI) and the Medical Monitor.
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