RZL-012 for Dercum's Disease Lipomas
Condition: Dercum's Disease Lipomas
MeSH terms: Lipoma; Adiposis Dolorosa
Intervention: RZL-012; Vehicle
Intervention description: small synthetic molecule for the treatment of Dercum's Disease lipomas; Vehicle of RZL-012 drug product
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

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.