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

• Status: Completed
• Trial end date: 2019-05-06
• Target enrollment: 0
• Participant gender: All

Summary

Lipedema and Dercum's disease are known as Rare Adipose Disorders; they are painful, progressive disorders that result in abnormal accumulations of fat in the form of lipomas, excess lymphatic fluid, and many other symptoms. This trial aims to study RZL-012, a novel compound, in treating lipedema and Dercum's disease by triggering lipolysis at selected sites and reducing fat bringing pain relief and improvement in quality of life.

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

Details

• Lead Sponsor: Raziel Therapeutics Ltd.
• Collaborator: University of Arizona

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. 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.