rzl-012 for dercum's disease lipomas

Conditions: Dercum's Disease Lipomas

Summary: thirty-eight (38) subjects will be included in the study. subjects will be randomized in a ration of 1:1 to be treated with rzl-012 or placebo. subjects will be injected with a different doses of rzl-012 according to their lipomas sizes. the total of 38 subjects will be enrolled in 3 clinical sites.

this is a multi-center, randomized, double blind, placebo controlled clinical trial in dd subjects having lipomas. subjects will be randomized, in a 1:1 ratio, into two groups injected with either rzl-012 or vehicle. once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will be offered the option of receiving treatment with rzl-012 and followed up for an additional 84 days. at least 4 lipomas/nodules, preferably 6, and no more than 8, will be injected per subject, two of which will be medium (4-5.9 cm), large (6-7.9 cm) or extra-large (8-10 cm) in diameter. dosing will be according to lipoma size, where the total injected dose will not exceed 240 mg per patient (48 injections at 5mg/injection).

Eligibility criteria:
inclusion criteria: * at least 4 painful lipomas of appropriate size to be injected on a background of dercum's disease. * generally considered healthy according to medical history, physical examination, electrocardiogram (ecg) and laboratory evaluation with an emphasis on metabolic parameters (fasting glucose concentration \< 200 mg/dl). * subjects must be able to adhere to the visit schedule and protocol requirements and be capable of completing the study. * males or females in the age of fertility are willing to refrain from sexual activity or agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with rzl 012. * subjects must sign an informed consent indicating they are aware of the investigational nature of the study. exclusion criteria: * unable to tolerate subcutaneous injections. * pregnant women. * subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator places the subject at significant risk. * positive blood screen for hepatitis b surface antigen (hbsag), hepatitis c virus (hcv), or human immunodeficiency virus (hiv). * subjects with a clinical history of active primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids * subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis. * as a result of medical review and physical examination, the pi (or medically qualified nominee) considers the subject unfit for the study. * known sensitivity to components of the injection formulation. * prior wound, tattoo or infection in the treated area. * prior invasive treatment such as surgery or injectable drug at the rzl-012 injected area. * subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs. * subjects treated chronically at least one week prior to study entry with non-steroidal anti-inflammatory drugs (nsaids). * current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.