RZL-012 for Dercum's Disease Lipomas
Dercum's Disease Lipomas
About this trial
This is an interventional treatment trial for Dercum's Disease Lipomas
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.
Sites / Locations
- Limitless Therapeutics
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
RZL-012
Vehicle of RZL-012
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL RZL-012 (5mg). Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL RZL-012 (20mg). 4-5.9 cm will be dozed with 0.8mL RZL-012 (80mg). 6-7.9 cm will be dozed with 1 mL RZL-012 (100mg). 8-10 cm will be dozed with 1.2 mL RZL-012 (120mg).
A single-treatment injection, multiple subcutaneous injections of vehicle administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL vehicle. Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL vehicle. 4-5.9 cm will be dozed with 0.8mL vehicle. 6-7.9 cm will be dozed with 1 mL vehicle. 8-10 cm will be dozed with 1.2 mL vehicle.