Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Arizona | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Within each cohort dosing of the subjects will progress consecutively from one individual to the other with a minimum 7 days between subjects to asses safety. The study design will allow the physicians to monitor safety for at least 7 days prior to dosing the next subject. Cohort 2 will be conducted in a dose escalation manner and the decision to proceed to the next dose level will be made after reviewing all safety data collected by Day 14 within 2+/-1 day of the last dosed subject. The trial will proceed within a cohort provided that no more than one subject experience intolerable side effects in a cohort, and based on the decision made by the Principal Investigator (PI) and the medical monitor.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Dercum's Disease | Active Comparator | Nodular size - diameter (cm) 2-2.9, 3-3.9, 4-8 Total dose of RZL-012(mg) 10 15 20 Dose per NOAEL 1/25th , 1/18.75th, 1/12.5th Number of injections: 2,3,4 |
|
| Cohort 2 - Lipedema | Active Comparator | Total dose of RZL-012 (mg) 60 , 80 Dose per NOAEL: 1/4.6888, 1/3.125 Number of injections: 12, 16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RZL-012 | Drug | The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort | Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort | 0-14 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
For lipedema - women only. For lipedema and Dercum- Post-menopausal women
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Dercum's Disease | Nodular size - diameter (cm) 2-2.9, 3-3.9, 4-8 Total dose of RZL-012(mg) 10 15 20 Dose per NOAEL 1/25th , 1/18.75th, 1/12.5th Number of injections: 2,3,4 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| FG001 | Cohort 2 - Lipedema 60mg | Total dose of RZL-012 (mg) 60 Number of injections: 12 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| FG002 | Cohort 2 Lipedema 80mg | Total dose of RZL-012 (mg) 80 Number of injections: 16 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Dercum's Disease | Nodular size - diameter (cm) 2-2.9, 3-3.9, 4-8 Total dose of RZL-012(mg) 10 15 20 Dose per NOAEL 1/25th , 1/18.75th, 1/12.5th Number of injections: 2,3,4 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort | Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort | Posted | Count of Participants | Participants | 0-14 days |
|
56 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Dercum's Disease | Nodular size - diameter (cm) 2-2.9, 3-3.9, 4-8 Total dose of RZL-012(mg) 10 15 20 Dose per NOAEL 1/25th , 1/18.75th, 1/12.5th Number of injections: 2,3,4 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 22 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Racheli Gueta | Raziel Therapeutics | 97289126941 | racheli@raziel-therapy.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2019 | Jan 15, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Jan 15, 2024 | SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065134 | Lipedema |
| D000274 | Adiposis Dolorosa |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008068 | Lipomatosis |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720429 | RZL-012 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cohort 2 - Lipedema 60mg |
Total dose of RZL-012 (mg) 60 Number of injections: 12 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| BG002 | Cohort 2 - Lipedema 80mg | Total dose of RZL-012 (mg) 80 Number of injections: 16 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cohort 2 Lipedema 80mg | Total dose of RZL-012 (mg) 80 Dose per Number of injections: 16 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2 - Lipedema 60 mg | Total dose of RZL-012 (mg) 60 Number of injections: 12, RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Cohort 2 - Lipedema 80 mg | Total dose of RZL-012 (mg) 80 Number of injections: 16 RZL-012: The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites | 0 | 3 | 0 | 3 | 3 | 3 |
| pain | General disorders | MedDRA 22 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22 | Non-systematic Assessment |
|
Not provided
Not provided
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |