Registry
Research
Understanding
Resources
Projects

Lipedema Foundation

Registry
Research
Understanding
Resources
Projects
  • Our Research
  • 2021 Request For Proposals
  • Applicant FAQ
  • Current Awardee FAQ
  • Research Impact
  • Research Grants
  • Research Strategy
  • Research Report
  • Live Research

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female, aged 18 years to 64 years old (at Screening), inclusive. 2. Body mass index (BMI) >18.5 kg/m2 at Screening and Day 1. 3. Has confirmed Dercum's disease and/or fulfills the following clinical criteria of Dercum's disease in localized nodular form. The final diagnosis of disease is in the opinion of the PI. 1. Chronic pain (> 3 months) in the adipose tissue. 2. Pain in and around multiple lipomas. 4. Has at least 4 painful and well defined lipomas with a diameter of ≥1.0 cm and ≤6.0 cm as determined by ultrasound. Excluding lipomas in proximity to vulnerable anatomic structures, including the salivary glands, lymph nodes, muscles, and along the anatomic landmarks of the marginal mandibular nerve. 5. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation. 6. Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the PI or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.

Exclusion Criteria:

1. Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who are currently pregnant or lactating. Male participants who are not willing to commit to an acceptable contraceptive method. Female participants who are not WOCBP are not required to use contraception. 2. Participants that are unable to tolerate subcutaneous injections. 3. Participants that are diagnosed with another disorder with similar characteristics as Dercum's Disease. 4. Participants that are diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation. 5. Participants who has fasting glucose concentration >200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of PI or designee, is inappropriate to participate in the study. 6. Participants with any clinically significant cardiac, hepatic, renal or neurologic/psychiatric disorders that in the opinion of the PI places the participant at significant risk. 7. Participants with positive blood screen for Hepatitis B surface antigen (HBsAg), Hepatitis C virus, or Human immunodeficiency virus (HIV). 8. Participants with clinical history of active primary or secondary immunodeficiency, autoimmune disease, or is undergoing chronic steroid or immunosuppressive therapy. 9. Participants with active, suspected, or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of the skin and in situ squamous cell carcinoma of the skin would be eligible as per PI's discretion. 10. Participants with abnormal skin, local skin conditions, or body modifications at the treatment area, which in the opinion of the PI, is inappropriate for participation in the study, including but not limited to prior wound, scar tissue, infection in the treated area, or tatoo in the treated area. 11. Participants requiring continual use of the following therapeutic agents during the study: terfenadine, buspirone, fexofenadine, any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. If a participant requires the abovementioned therapeutic agents during the study for any reason, they should not be used for at least 2 days before dosing and until 1 day postdose. 12. Participants that undergone aesthetic procedure (eg, liposuction, cryolipolysis, ultrasonic lipolysis, low level laser therapy [LLLT], lipolysis injection) to the region to be treated before Screening or during the study. 13. Participants who are unable to receive local anesthesia. 14. Participants with known allergies or sensitivities to the IP or its components. 15. Participants that are in use of other investigational drug or device within 4 weeks prior to Screening. 16. Participant who has undergone vaccination (including with a live-attenuated vaccine) within 14 days prior to administration of the IP.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05387733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Caliway Biopharmaceuticals Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anne Sheu
Principal Investigator Affiliation Caliway Biopharmaceuticals Co., Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dercum's Disease
Additional Details

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, randomized study design. Eligible participants will have at least 4 painful lipomas of appropriate size and up to 8 lipomas will be treated per subject. Eligible participants will be enrolled and randomized to 2 dose groups, with 6 participants per group. Each enrolled participant will receive up to 2 courses of their allocated dose of CBL-514 administered into selected lipomas, which the injection volume per lipoma will be based on the lipoma size, determined by ultrasound.

Arms & Interventions

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.

Interventions

Drug: - 10 mg CBL-514 per injection

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.

Drug: - 15 mg CBL-514 per injection

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Karen L. Herbst, MD, PC, Tucson, Arizona

Status

Recruiting

Address

Karen L. Herbst, MD, PC

Tucson, Arizona, 85711

Site Contact

Karen L Herbst

[email protected]

+886-2-26971355

Nearest Location

Site Contact

Karen L Herbst

[email protected]

+886-2-26971355

Powered By

The content provided in the Lipedema Foundation Legwork program is for informational purposes and does not, under any circumstance, constitute medical advice. Consult with your healthcare provider regarding any changes to your lipedema treatment including participation in any study. Information provided here is maintained by the TrialScope vendor and supplied by the individual study teams. Use of the TrialScope service requires acceptance of the TrialScope privacy policy and terms of service. Some features of the service may require registration of the user's contact information with TrialScope through the TrialScope website. Do not register if you do not consent to providing such information. The Lipedema Foundation does not guarantee that the contents are accurate or complete, or that any given study will be available for participation or applicable to your condition. The listing of a study on the site does not constitute an endorsement or recommendation of that study by the Lipedema Foundation. As such, you hereby waive claims and liability against the Lipedema Foundation for any harm, including bodily injury and death, that may result in connection with the use of this service. The Lipedema Foundation reserves the right, at its discretion, to omit studies or add studies to the service without notice. The Lipedema Foundation does not represent that the list of studies presented through the service is complete.

Join Our Email List
Back to Top
39 Lewis Street, 4th Floor, Greenwich, CT 06830, USA2034892989[email protected]

All contents of the Lipedema Foundation Website are Copyright © 2016-2021. The content, text, graphics, data, and services offered herein (the "Content") are provided solely to educate consumers on health care and medical issues that may affect their daily lives. Nothing in the Content should be considered, or used as a substitute for, medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. If you are in the United States and are experiencing a medical emergency, please call 911 or call for emergency medical help on the nearest telephone. Reliance on the Content or any portion thereof, or other visitors to the web site, is solely at your own risk.