CBL-514 Injections for Adiposis Dolorosa

Recruiting at 1 trial location

Overseen By Tim Wu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, Analgesics, Cannabis, others

Disqualifiers: Pregnancy, Coagulation disorders, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 20 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called CBL-514, an injection for individuals with Dercum's Disease, which causes painful lumps of fat under the skin. The trial aims to determine if these injections can safely reduce pain and the size of these fatty lumps. Participants will receive either CBL-514 or a placebo (a harmless substitute) to compare results. Suitable candidates for this trial have experienced chronic pain from multiple painful lumps for at least three months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that CBL-514 injections are likely to be safe for humans?

Research has shown that CBL-514 was tested in people with Dercum's disease, a condition that causes painful fatty lumps called lipomas. The results were positive: 64.5% of these lipomas either disappeared or shrank by more than half after treatment. This suggests that CBL-514 is generally safe for people. Since this study is in Phase 2, it builds on earlier safety data, indicating the treatment has shown a reasonable level of safety in humans so far. However, like any treatment, side effects can occur, so discussing potential risks with the trial team before joining is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CBL-514 injections for Adiposis Dolorosa because this treatment offers a novel approach by directly targeting and breaking down the fat tissue in lipomas. Unlike standard treatments like surgery or pain management, CBL-514 is a non-invasive injection that can potentially dissolve the painful lipomas without the need for surgical removal. This could make it a less painful and more convenient option for patients, with the added benefit of potentially reducing recurrence rates by addressing the underlying fat tissue directly.

What evidence suggests that CBL-514 might be an effective treatment for Dercum's Disease?

Research has shown that CBL-514 injections, which participants in this trial may receive, might help treat lipomas caused by Dercum's Disease. In earlier studies, 64.5% of these painful lumps of fat under the skin either disappeared or shrank by more than half after treatment with CBL-514. This suggests that CBL-514 could significantly reduce the size of these lipomas. Although the treatment remains under investigation, these early findings offer hope for people with Dercum's Disease. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CBL-514 injection Experimental Treatment 1 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 Chloride Placebo Group 1 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:

Approved in European Union as CBL-514 for:

• Dercum's disease

Approved in United States as CBL-514 for:

• Dercum's disease

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine for the treatment of intractable pain of adiposis dolorosa. Atkinson, RL.[2014]

A 53-year-old man with adiposis dolorosa experienced significant pain relief after receiving intravenous lidocaine, suggesting its potential efficacy as a treatment for this condition.

In-vitro studies indicated that painful adipose tissue showed reduced glucose conversion to neutral glycerides, which may provide insights into the underlying mechanisms of adiposis dolorosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of adiposis dolorosa: lipid metabolism and hormone secretion. Taniguchi, A., Okuda, H., Mishima, Y., et al.[2018]

Juxta-articular adiposis dolorosa is a distinct condition characterized by painful fat accumulation near joints, particularly the knee, and should be differentiated from other knee pain causes.

The paper presents two case studies and discusses various treatment options, proposing a classification system for different types of painful fat near joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Juxta-articular adiposis dolorosa: what is it? Report of 2 cases. Eisman, J., Swezey, RL.[2019]

In a pilot study involving 10 HIV-infected subjects with buttock lipoatrophy, Macrolane VRF30 injections significantly reduced pain and increased the time subjects could sit comfortably for up to 9 months after treatment.

The treatment was well-tolerated, with only five mild adverse events related to the injection procedure, indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of HIV-Infected Subjects with Buttock Lipoatrophy Using Stabilized Hyaluronic Acid Gel. Claude, O., Bosc, R., Pigneur, F., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The latest practice advisory on gluteal fat grafting emphasizes the importance of surgical technique to prevent fatal complications, particularly in Brazilian Butt Lifts (BBL), which have been linked to several patient deaths.

Key recommendations include using ultrasound guidance for fat injection to ensure correct placement and limiting surgeons to a maximum of 3 BBL procedures per day to reduce fatigue and distraction, which are associated with increased surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Advisory on Gluteal Fat Grafting. Del Vecchio, D., Kenkel, JM.[2022]

A unique case of a patient with adrenal insufficiency developed multifocal lipoatrophy lesions after receiving intravenous corticosteroids, suggesting a potential adverse reaction to this treatment method.

This case highlights the need for further investigation into the safety of intravenous corticosteroids, as lipoatrophy has typically been associated with improper intradermal injections rather than intravenous administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifocal disseminated lipoatrophy secondary to intravenous corticosteroid administration in a patient with adrenal insufficiency. Bauerschmitz, J., Bork, K.[2019]

In a pilot study of 10 participants with adiposis dolorosa, the Cyclic Variations in Altitude Conditioning™ (CVAC™) 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study: rapidly cycling hypobaric pressure improves pain after 5 days in adiposis dolorosa. Herbst, KL., Rutledge, T.[2021]

Obesity, defined as a BMI of 30 kg/m2 or higher, is associated with an increased risk of postoperative complications such as seromas and hematomas following cosmetic abdominal body contouring procedures, based on a systematic review of 16 studies involving pooled data from 9 studies.

Despite the increased risk of certain complications, the severity of obesity does not correlate with a higher risk of complications, suggesting that a BMI ≥ 30 kg/m2 should not automatically disqualify patients from undergoing cosmetic abdominal procedures; evaluations should be made on an individual basis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity as a Risk Factor in Cosmetic Abdominal Body Contouring: A Systematic Review and Meta-Analysis. Niu, EF., Honig, SE., Wang, KE., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05387733

A Study to Evaluate the Efficacy and Safety of CBL-514 in ... 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, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05387733?cond=%22Adiposis%20dolorosa%22&rank=2

A Study to Evaluate the Efficacy and Safety of CBL-514 in ... 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.

3. caliwaybiopharma.com caliwaybiopharma.com/en/news-detail/cbl-0201dd-results/

The Positive Topline Results from the CBL-514 Phase 2 ... 64.5% of painful lipomas showed complete clearance or dimensions reduction of more than 50% after CBL-514 treatments.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/caliway-cbl-514/

FDA clears Caliway's trial of CBL-514 for localised fat ... The top-line outcomes from SUPREME-01 are anticipated between the fourth quarter of 2026 and the first quarter of 2027. Recruitment for the ...

5. trials.lipedema.org trials.lipedema.org/trials/NCT05387733

A Study to Evaluate the Efficacy and Safety of CBL-514 in ... 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.