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

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 3, 2022

Primary Completion Date

April 3, 2023

Study Completion Date

April 3, 2023

Conditions
Dercum's Disease
Interventions
DRUG

10 mg CBL-514 per injection

"The total injection volume per lipoma will be based on the lipoma size, as determined by ultrasound. Dosing sceme is presented as below:~Lipoma diameter of ≥1.0cm and ≤2.0cm - 1 injection (2 mL each); total of 10 mg CBL-514.~Lipoma diameter of \>2.0cm and ≤3.5cm - 2 injections (2 mL each); total of 20 mg CBL-514.~Lipoma diameter of \>3.5cm and ≤5.0cm - 3 injections (2 mL each); total of 30 mg CBL-514.~Lipoma diameter of \>5.0cm and ≤6.0cm - 5 injections (2 mL each); total of 50 mg CBL-514."

DRUG

15 mg CBL-514 per injection

"The total injection volume per lipoma will be based on the lipoma size, as determined by ultrasound. Dosing sceme is presented as below:~Lipoma diameter of ≥1.0cm and ≤2.0cm - 1 injection (3 mL each); total of 15 mg CBL-514.~Lipoma diameter of \>2.0cm and ≤3.5cm - 2 injections (3 mL each); total of 30 mg CBL-514.~Lipoma diameter of \>3.5cm and ≤5.0cm - 3 injections (3 mL each); total of 45 mg CBL-514.~Lipoma diameter of \>5.0cm and ≤6.0cm - 5 injections (3 mL each); total of 75 mg CBL-514."

Trial Locations (1)

85711

Karen L. Herbst, MD, PC, Tucson

All Listed Sponsors
lead

Caliway Biopharmaceuticals Co., Ltd.

INDUSTRY

NCT05387733 - A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas | Biotech Hunter | Biotech Hunter