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Completed NCT06303570

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

Conditions: Dercum's Disease

Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 19
Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Location: Investigator Site Spokane Washington

Summary

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

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 DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator. 1. Chronic pain (\>3 months) in the adipose tissue specific to the presence of lipomas and/or 2. Pain in and around multiple lipomas. 4. Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10 mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening. 5. Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation. 6. Voluntarily signs the informed consent form (ICF) and, in the opinion of the Investigator or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures. Exclusion Criteria: 1. Female participant of childbearing potential who is 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 is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose. 2. Unable to tolerate SC injections. 3. Diagnosed with another disorder with similar characteristics as DD as follows. 1. Madelung's disease: multiple symmetric lipomatosis only localized in the upper body ie, shoulders, neck, or head. 2. Panniculitis: inflammation of the SC adipose tissue, characterized by tender nodules and systemic signs. 3. Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fatty and connective tissue. 4. PTEN hamartoma syndrome: multiple hamartomas which includes segmental overgrowth, lipomatosis, arteriovenous malformation, and epidermal nevus. 5. Gardner syndrome: multiple digestive adenomas with osteomas and multiple skin and soft tissue tumors. 4. Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation. 5. Has fasting glucose concentration \>200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of the Investigator or designee, is inappropriate to participate in the study. 6. Any clinically significant cardiac, hepatic, renal or neurologic/psychiatric disorders that in the opinion of the Investigator places the participant at significant risk, including but not limited to any of the following: 1. Participants with cirrhosis or with inadequate liver function at screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin \>3.0 upper limit of normal (ULN). 2. Participants with renal impairment, defined as both serum creatinine and blood urea nitrogen \>1.5× ULN, or estimated glomerular filtration rate (eGFR) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06303570). StuddyBuddy aggregates publicly available trial information.