Evaluation of Safety and Efficacy of RZL-012 for the Treatment of Lipedema or of Nodular Dercum's Disease
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|ClinicalTrials.gov Identifier: NCT03492840|
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lipedema Dercum Disease||Drug: RZL-012||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||An open label clinical trial - subjects will receive the investigational drug only|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Phase 2a Clinical Trial for the Evaluation of Safety and Efficacy of RZL-012 for the Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||May 6, 2019|
|Actual Study Completion Date :||May 6, 2019|
A single-time injection, multiple subcutaneous injections of RZL-012 administered into the subcutaneous fat.
Dercum's disease - dosing according to nodule size:
Nodule of 2-2.9cm - 2 injections (0.1 mL each); total of 10 mg RZL-012.
Nodules of 3-3.9cm - 3 injections (0.1 mL each); total of 15 mg RZL-012.
Nodules of 4-8cm - 4 injections (0.1 mL each); total of 20 mg RZL-012.
2 subjects will receive 20mg RZL-012 in 4 injections in each leg adding up to 8 injections of 40mg RZL-012.
2 subjects will receive 30mg RZL-012 in 6 injections in each leg adding up to 12 injections of 60mg RZL-012.
2 subjects will receive 40mg RZL-012 in 8 injections in each leg adding up to 16 injections of 80mg RZL-012.
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 2-16 sites (0.1mL per site) into the subcutaneous fat.
- The incidence of intolerable side effects (a related adverse event) as defined in the protocol. [ Time Frame: 0-56 days ]Adverse events [AEs] will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)
- For lipedema subjects - The reduction of fat above the knee in the injection site region [ Time Frame: 0-56 days ]Evaluated by measurement of leg circumference above the knee compared to baseline.
- For Dercum's disease subjects - The reduction in local subcutaneous fat in the injection site region. [ Time Frame: 0-56 days ]Evaluated by the reduction in nodules size and/or n number of nodules as assessed by ultrasound compared to baseline
- Extended duration of the fat reduction effect [ Time Frame: 0-56 days ]Assessed by leg circumference measurement that will be followed for 56 days
- Elucidation of the tissue changes [ Time Frame: 0-56 days ]Assessed by nodular quality at the injection site by ultrasound and compared to baseline
- Improvement in local pain [ Time Frame: 0-56 days ]Assessed by the Comparative Pain Scale and compared to baseline. Comparative Pain Scale ranges are: 1-3 Minor pain, 4-6 Moderate pain, 7-10 Severe pain. Higher values represent worst outcome.
- Improvement in pain [ Time Frame: 0-56 days ]Assessed by reduction in the use of analgesics and compared to baseline.
- Improvement in physical function in lipedema subjects [ Time Frame: 0-56 days ]Assessed by The Lower Extremity Functional Scale (LEFS). LEFS is used to assess if the patient has difficulties in their physical function activities. For each physical function activity the range is 1-4 when higher values are considered worse outcome. Subscales are combined to compute a total score. The percentage of physical function is calculated by dividing the total score by 80.
- For lipedema subjects - The reduction in local subcutaneous fat in the injection site region [ Time Frame: 0-56 days ]Assessed by ultrasound images that will be followed for 56 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492840
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Karen Herbst, MD||University of Arizona|