NCT06303570

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

A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.

Detailed description

This is a phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's disease lipomas. A total of approximately 25 participants will be randomized. Eligible participants will be randomized (1:1) to receive either CBL-514 or placebo once every 4 weeks for up to 5 treatments for each selected lipoma. Participant numbers are expected to be approximately balanced in each dose group (CBL-514 group and placebo group). Eligible participants must have at least 4 and up to 10 painful individual lipomas. The injection volume per lipoma will depend on the lipoma size (as determined by ultrasound).

Conditions

• Dercum's Disease

Interventions

Type	Name	Description
DRUG	CBL-514 injection	The total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below: Lipoma diameter of \>0mm and \<10mm - total injection volume per lipoma: 1 mL ; total of 5 mg CBL-514. Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL ; total of 15 mg CBL-514. Lipoma diameter of \>20mm and ≤30mm - total injection volume per lipoma: 5 mL ; total of 25 mg CBL-514. Lipoma diameter of \>30mm and ≤40mm - total injection volume per lipoma: 8 mL ; total of 40 mg CBL-514. Lipoma diameter of \>40mm and ≤50mm - total injection volume per lipoma: 12 mL ; total of 60 mg CBL-514.
DRUG	0.9% Sodium chloride	The total injection volume per lipoma will based on the lipoma size,as determined by ultrasound. Dosing scheme is presented as below: Lipoma diameter of \>0mm and \<10mm - total injection volume per lipoma: 1 mL. Lipoma diameter of ≥10mm and ≤20mm - total injection volume per lipoma: 3 mL. Lipoma diameter of \>20mm and ≤30mm - total injection volume per lipoma: 5 mL. Lipoma diameter of \>30mm and ≤40mm - total injection volume per lipoma: 8 mL. Lipoma diameter of \>40mm and ≤50mm - total injection volume per lipoma: 12 mL.

Timeline

• Start date: 2024-11-27
• Primary completion: 2026-03-23
• Completion: 2026-04-01
• First posted: 2024-03-12
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study