RZL-012 for Dercum's Disease Lipomas (NCT04229030) | Clinical Trial Compass
CompletedPhase 2
RZL-012 for Dercum's Disease Lipomas
United States38 participantsStarted 2020-07-30
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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…