A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
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.
• 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 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.
‣ Chronic pain (\>3 months) in the adipose tissue specific to the presence of lipomas and/or
⁃ Pain in and around multiple lipomas.
• 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.
• Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation.
• 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.