Evaluation of Safety and Efficacy of RZL-012 for the Treatment of Lipedema or of Nodular Dercum's Disease

A vast amount of published information proves that for some people, obesity is not the result
of excessive food consumption, poor food choices, and failure to exercise . Problems with
mitochondria, leaky lymphatics and other mutations can drive and maintain fat growth that
cannot be lost through traditional diet and exercise. Lipedema and Dercum's disease are known
as Rare Adipose Disorders. These are painful and progressive disorders that result in
abnormal accumulations of fat in the form of lipomas, excess lymphatic fluid, and many other
symptoms.

RZL-012 is a novel molecule that enables de-novo generation of thermogenic tissue at
favorable anatomical sites. As a result, the extra accumulated fat will be turned into heat
and induce lipolysis. This is an open label , Phase 2a clinical trial for the evaluation of
safety, efficacy and lipolysis-induction of RZL-012 in women with lipedema involving
substantial fat above the knee or women and men with nodular Dercum's disease.

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. Subjects with stable weight in the last 3 months by medical history.

3. For Dercum's disease subjects - at least 2 nodules to be injected of at least 2cm
diameter each, as determined by ultrasound

4. For lipedema subjects - Significant subcutaneous fat above the knee as determined by
circumference of 50cm

5. 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).

6. Subjects must be able to adhere to the visit schedule and protocol requirements and be
available to complete the study.

7. 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.