NCT04229030

RZL-012 for Dercum's Disease Lipomas

A Double Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2B Clinical Trial for the Evaluation of Efficacy and Safety of RZL-012 in Subjects Having Dercum's Disease Lipomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Raziel Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Thirty-eight (38) subjects will be included in the study. Subjects will be randomized in a ration of 1:1 to be treated with RZL-012 or placebo. Subjects will be injected with a different doses of RZL-012 according to their lipomas sizes. The total of 38 subjects will be enrolled in 3 clinical sites.

Detailed description

This is a multi-center, randomized, double blind, placebo controlled clinical trial in DD subjects having lipomas. Subjects will be randomized, in a 1:1 ratio, into two groups injected with either RZL-012 or vehicle. Once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will be offered the option of receiving treatment with RZL-012 and followed up for an additional 84 days. At least 4 lipomas/nodules, preferably 6, and no more than 8, will be injected per subject, two of which will be medium (4-5.9 cm), large (6-7.9 cm) or extra-large (8-10 cm) in diameter. Dosing will be according to lipoma size, where the total injected dose will not exceed 240 mg per patient (48 injections at 5mg/injection).

Conditions

• Dercum's Disease Lipomas

Interventions

Type	Name	Description
DRUG	RZL-012	small synthetic molecule for the treatment of Dercum's Disease lipomas
DRUG	Vehicle	Vehicle of RZL-012 drug product

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-02-20
• Completion: 2021-02-20
• First posted: 2020-01-14
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study