NCT05387733

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dercum's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2022-05-24
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study