Phase 2
N=38
RZL-012 for Dercum's Disease Lipomas
Dercum's Disease Lipomas
Bottom Line
View on ClinicalTrials.gov: NCT04229030 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Efficacy - Change in Lipomas Dimensions — -15.13; -15.92 percentage of change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RZL-012 (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Raziel Therapeutics Ltd.
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy - Change in Lipomas Dimensions |
-15.13; -15.92 | — |
| SECONDARY Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas |
-56.15; -34.34 | — |
| SECONDARY Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28 |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04229030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.