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

Conditions

• Dercum's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• CBL-514 injection — DRUG
  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.
• 0.9% Sodium chloride — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 27, 2024

Status verified

Mar 2026

Primary completion

Mar 23, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

19 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBL-514 injection
  Eligible participants will receive CBL-514 administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments.
• Placebo Comparator: 0.9% Sodium Chloride
  Eligible participants will receive 0.9% Sodium Chloride administered in doses ranging from 1 mL to a maximum of 12 mL per lipoma, with treatments scheduled at intervals of approximately 4 weeks, up to 5 treatments.

Primary Outcome Measure

To estimate the treatment effect, as measured by pain, between CBL-514 and placebo in participants with DD. [ Time Frame: Week 20 ]

Locations (1)

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