RZL-012 for Dercum's Disease Lipomas

• Status: Completed
• Trial end date: 2021-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Raziel Therapeutics Ltd.

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.