A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

Dercum's Disease Clinical Trial

Official title: An Open-Label, Randomized Phase 2a Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

Status Completed

Clinical Trial Summary

This Phase 2 study will be an open-label and randomized study to assess the efficacy and safety of CBL-514 in participants with Dercum's Disease lipomas.

Clinical Trial Description

This is a Phase 2a study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's disease. It will employ an open-label, randomized study design.

Eligible participants will have at least 4 painful lipomas of appropriate size and up to 8 lipomas will be treated per subject. Eligible participants will be enrolled and randomized to 2 dose groups, with 6 participants per group. Each enrolled participant will receive up to 2 courses of their allocated dose of CBL-514 administered into selected lipomas, which the injection volume per lipoma will be based on the lipoma size, determined by ultrasound. ;

Related Conditions & MeSH terms

• Dercum's Disease

• NCT number: NCT05387733
• Study type: Interventional
• Source: Caliway Biopharmaceuticals Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2022
• Completion date: April 3, 2023