30 Participants Needed

CBL-514 Injections for Adiposis Dolorosa

Recruiting at 1 trial location
SL
Overseen BySandy Liu
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

There is no direct data on CBL-514 for adiposis dolorosa, but a study suggests it may reduce abdominal fat, which could indirectly help with symptoms. Other treatments like lidocaine have shown pain relief in adiposis dolorosa, indicating that targeting fat tissue can be beneficial.12345

Is CBL-514 safe for use in humans?

CBL-514 has been studied for reducing abdominal fat and is suggested to be safe for this purpose, though specific safety data is limited.16789

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

My BMI is over 18.5.
My condition is confirmed or suspected to be DD by my doctor.
I have had chronic pain for more than 3 months due to lipomas.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBL-514 or placebo injections every 4 weeks for up to 5 treatments

20 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
2 visits (in-person)

Treatment Details

Interventions

  • CBL-514
Trial Overview The study tests the effectiveness of CBL-514 injections versus placebo (saltwater solution) in reducing pain from DD lipomas. It's a phase 2 trial where participants are randomly assigned to receive either the real drug or placebo without knowing which one they get.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBL-514 injectionExperimental Treatment1 Intervention
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.
Group II: 0.9% Sodium ChloridePlacebo Group1 Intervention
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.

CBL-514 is already approved in European Union, United States for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as CBL-514 for:
  • Dercum's disease
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as CBL-514 for:
  • Dercum's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials
11
Recruited
550+

Findings from Research

CBL-514, an injectable drug, was found to be safe and effective in reducing abdominal subcutaneous fat volume and thickness, with a significant reduction of 24.96% at the highest dose of 2.0 mg/cm2.
The treatment induced adipocyte apoptosis, which is the mechanism by which it reduces fat, and was well-tolerated across multiple doses, making it a promising option for nonsurgical fat reduction in dermatology.
Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction.Goodman, GJ., Ho, WWS., Chang, KJ., et al.[2022]
In a pilot study of 10 participants with adiposis dolorosa, the Cyclic Variations in Altitude Conditioningโ„ข (CVACโ„ข) process significantly reduced pain levels and improved mental quality of life after 5 days of treatment.
Participants also experienced weight loss and decreased bioimpedance, suggesting potential benefits in managing symptoms associated with adiposis dolorosa, although further randomized controlled trials are needed to confirm these findings.
Pilot study: rapidly cycling hypobaric pressure improves pain after 5 days in adiposis dolorosa.Herbst, KL., Rutledge, T.[2021]
A patient with adiposis dolorosa experienced significant pain relief from intravenous lidocaine infusions over a two-year period, with effects lasting between two to twelve months after each treatment.
The treatment was ineffective for other types of pain, such as diabetic neuropathy and angina, suggesting that lidocaine's pain-relieving effects may be specific to adiposis dolorosa and possibly linked to its central nervous system effects.
Intravenous lidocaine for the treatment of intractable pain of adiposis dolorosa.Atkinson, RL.[2014]

References

Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction. [2022]
Pilot study: rapidly cycling hypobaric pressure improves pain after 5 days in adiposis dolorosa. [2021]
Intravenous lidocaine for the treatment of intractable pain of adiposis dolorosa. [2014]
A case of adiposis dolorosa: lipid metabolism and hormone secretion. [2018]
Juxta-articular adiposis dolorosa: what is it? Report of 2 cases. [2019]
Multifocal disseminated lipoatrophy secondary to intravenous corticosteroid administration in a patient with adrenal insufficiency. [2019]
Practice Advisory on Gluteal Fat Grafting. [2022]
Obesity as a Risk Factor in Cosmetic Abdominal Body Contouring: A Systematic Review and Meta-Analysis. [2023]
Treatment of HIV-Infected Subjects with Buttock Lipoatrophy Using Stabilized Hyaluronic Acid Gel. [2020]
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