CompletedPhase 2

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

United States12 participantsStarted 2022-10-03

Plain-language summary

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.

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
✓. Body mass index (BMI) \>18.5 kg/m2 at Screening and Day 1.
✓. 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.
✓. Chronic pain (\> 3 months) in the adipose tissue
✓. Pain in and around multiple lipomas.
✓. 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.
✓. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation.
✓. 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

✕. 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.
✕. Participants that are unable to tolerate subcutaneous injections.
✕. Participants that are diagnosed with another disorder with similar characteristics as Dercum's Disease.
✕. Participants that are diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation.
✕. 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.
✕. 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.
✕. Participants with positive blood screen for Hepatitis B surface antigen (HBsAg), Hepatitis C virus, or Human immunodeficiency virus (HIV).
✕. Participants with clinical history of active primary or secondary immunodeficiency, autoimmune disease, or is undergoing chronic steroid or immunosuppressive therapy.

What they're measuring

Efficacy of CBL-514 following injection into lipomas or nodules of participants with Dercum's disease.

Timeframe: 0-84 days

Trial details

NCT IDNCT05387733

SponsorCaliway Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-03

View on ClinicalTrials.gov More Dercum's Disease trials