Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
Condition: Lipedema; Dercum Disease
MeSH terms: Lipedema; Adiposis Dolorosa
Intervention: RZL-012
Intervention description: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat
      above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will
      receive RZL-012.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Post-menopausal (at least 2 years) women no more than 65 years old, with lipedema
             involving substantial fat above the knee or nodular Dercum's disease in such women and
             in men 20 - 65 years with nodular Dercum's disease.

          2. For Dercum's disease subjects - at least 2 nodules to be injected of at least 2cm
             diameter each, as determined by ultrasound

          3. For lipedema subjects - Significant subcutaneous fat above the knee as determined by
             circumference of 50cm

          4. Generally considered healthy according to medical history, physical examination, ECG
             and laboratory evaluation with a special emphasis on metabolic parameters (fasting
             glucose concentration < 100 mg, normal blood pressure).

          5. Subjects must be able to adhere to the visit schedule and protocol requirements and be
             available to complete the study.

          6. Subjects must sign an informed consent indicating that they are aware of the
             investigational nature of the study.

        Exclusion Criteria:

          1. Unable to tolerate subcutaneous injection.

          2. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric
             disorders, that in the opinion of the investigator, put the subject at significant
             risk, are not eligible.

          3. Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus
             (HCV), or Human immunodeficiency virus (HIV), or positive urine screen for alcohol or
             drugs of abuse (unless prescribed by a physician).

          4. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune
             disease or subjects taking immunosuppressive drugs such as corticosteroids are
             ineligible.

          5. As a result of medical review, physical examination, the PI (or medically qualified
             nominee) considers the subject unfit for the study.

          6. Known sensitivity to components of the injection formulation.

          7. Prior wound, tattoo or infection in the treated area.

          8. Prior invasive treatment such as surgery or injectable drug at the RZL-012 injected
             area.