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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT05387733
Phase
PHASE2
Status
Completed

Conditions

  • Dercum's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 10 mg CBL-514 per injection — DRUG
    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.
  • 15 mg CBL-514 per injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 3, 2022
Status verified
Apr 2023
Primary completion
Apr 3, 2023
Completion
Apr 3, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 Group 1
    Eligible participants will be enrolled and randomized into one of 2 dose groups. Group 1 with 10 mg CBL-514 per injection.
  • Experimental: CBL-514 Group 2
    Eligible participants will be enrolled and randomized to one of 2 dose groups. Group 2 with 15 mg CBL-514 per injection.

Primary Outcome Measure

Efficacy of CBL-514 following injection into lipomas or nodules of participants with Dercum's disease. [ Time Frame: 0-84 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Karen L. Herbst, MD, PCTucsonArizona85711-

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Karen L. Herbst, MD, PC· Tucson, AZ