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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 27, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2026

Conditions
Dercum's Disease
Interventions
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."

Trial Locations (1)

99204

RECRUITING

Investigator Site, Spokane

All Listed Sponsors
lead

Caliway Biopharmaceuticals Co., Ltd.

INDUSTRY