CBL-514 Injections for Adiposis Dolorosa
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use any analgesics (pain relievers) including Cannabis within 14 days before screening. Also, you cannot use medications that strongly affect certain liver enzymes during the study, unless you stop them at least 2 days before and 1 day after dosing.
What data supports the effectiveness of the drug CBL-514 for treating adiposis dolorosa?
Is CBL-514 safe for use in humans?
How does the drug CBL-514 differ from other treatments for adiposis dolorosa?
CBL-514 is a novel injectable drug that targets fat cells for reduction, which is different from other treatments for adiposis dolorosa that focus on pain relief, such as intravenous lidocaine or noninvasive methods like pneumatic compression. This approach may offer a new way to address the underlying fat accumulation in adiposis dolorosa.12345
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for adults aged 18-64 with Dercum's Disease (DD), characterized by painful lipomas and a BMI over 18.5. Participants must have chronic pain in adipose tissue, at least four well-defined lipomas between 10mm and 50mm, not near sensitive areas like glands or nerves.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CBL-514 or placebo injections every 4 weeks for up to 5 treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CBL-514
CBL-514 is already approved in European Union, United States for the following indications:
- Dercum's disease
- Dercum's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Caliway Biopharmaceuticals Co., Ltd.
Lead Sponsor