LipedemaPhase 2NCT03492840
Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
A Phase 2 study testing RZL-012 in people with Lipedema and Dercum Disease, run by Raziel Therapeutics Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lipedema, Dercum Disease
- What is being tested?
- RZL-012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 2 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
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
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.
Read the detailed description
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.
- The 1st cohort will be comprised of subjects with Dercum's disease.
- The 2nd cohort will be comprised of subjects with lipedema with substantial fat above the knee
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.
- Conditions
- Lipedema, Dercum Disease
- Being tested
- RZL-012
- Medical subject headings
- Lipedema, Adiposis Dolorosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZL-012Drug
The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: RZL-012 |
| 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 Receives: Drug: RZL-012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start28 Jun 2018
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raziel Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492840
- Sponsor's protocol ID
- RZL-012-FD-P2aUS-001.70
- Status last verified
- Apr 2019
- First submitted
- 19 Feb 2018
- Last updated
- 8 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03492840
- Acronym / sponsor ID
- RZL-012-FD-P2aUS-001.70
- Conditions
- Lipedema, Dercum Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Posted 8 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- The 1st cohort will be comprised of subjects with Dercum's disease.
- The 2nd cohort will be comprised of subjects with lipedema with substantial fat above the knee
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Dercum's Disease | Active comparator | Drug: RZL-012Nodular 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 | Drug: RZL-012Total dose of RZL-012 (mg) 60 , 80 Dose per NOAEL: 1/4.6888, 1/3.125 Number of injections: 12, 16 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RZL-012The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites | Drug | Cohort 1 - Dercum's Disease, Cohort 2 - Lipedema |
Primary outcome
The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort
Time frame: 0-14 days
Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RZL-012 in people with Lipedema and Dercum Disease, run by Raziel Therapeutics Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort (time frame: 0-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.