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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04076891
Study type Interventional
Source Raziel Therapeutics Ltd.
Contact
Status Completed
Phase Phase 2
Start date June 28, 2018
Completion date May 2, 2019

See also
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