Phase 2
N=12
Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
Lipedema · Dercum Disease
Bottom Line
View on ClinicalTrials.gov: NCT03492840 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RZL-012 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Raziel Therapeutics Ltd.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort |
0; 0; 0 | — |
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
- 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.
- For Dercum's disease subjects - at least 2 nodules to be injected of at least 2cm diameter each, as determined by ultrasound
- For lipedema subjects - Significant subcutaneous fat above the knee as determined by circumference of 50cm
- 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).
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
Exclusion Criteria
- Unable to tolerate subcutaneous injection.
- 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.
- 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).
- Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
- As a result of medical review, 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.
Data sourced from ClinicalTrials.gov (NCT03492840). 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.