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.
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.