A Phase 2 interventional study of RZL-012 in Lipedema and Dercum Disease, sponsored by Raziel Therapeutics Ltd.. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Raziel Therapeutics Ltd. · Phase 2, Interventional, and Treatment
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 12 is below the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →Raziel Therapeutics Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: RZL-012
Total dose of RZL-012 (mg) 60 , 80 Dose per NOAEL: 1/4.6888, 1/3.125 Number of injections: 12, 16
Drug: RZL-012
The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites
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
Time frame: 0-14 days
| Milestone | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 Lipedema 80mg |
|---|---|---|---|
| Started | 6 | 3 | 3 |
| Completed | 6 | 3 | 3 |
| Not completed | 0 | 0 | 0 |
Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort
| Participants | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 Lipedema 80mg |
|---|---|---|---|
| The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort | 0 | 0 | 0 |
Collected over 56 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 - Dercum's Disease | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 2 - Lipedema 60 mg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 2 - Lipedema 80 mg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60 mg | Cohort 2 - Lipedema 80 mg |
|---|---|---|---|
| Injection site painGeneral disorders | 2/6 | 2/3 | 1/3 |
| painGeneral disorders | 2/6 | 1/3 | 1/3 |
| HeadacheNervous system disorders | 1/6 | 1/3 | 1/3 |
| ContusionInjury, poisoning and procedural complications | 1/6 | 1/3 | 0/3 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/6 | 1/3 | 1/3 |
| Age, Continuous(Years) | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 - Lipedema 80mg | Total |
|---|---|---|---|---|
| Mean | 57.3 ± 6.3 | 57.3 ± 5.0 | 57.3 ± 5.0 | 57.3 ± 5.4 |
| Sex: Female, Male(Participants) | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 - Lipedema 80mg | Total |
|---|---|---|---|---|
| Female | 1 | 3 | 3 | 7 |
| Male | 5 | 0 | 0 | 5 |
| Race (NIH/OMB)(Participants) | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 - Lipedema 80mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 5 | 3 | 3 | 11 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1 - Dercum's Disease | Cohort 2 - Lipedema 60mg | Cohort 2 - Lipedema 80mg | Total |
|---|---|---|---|---|
| United States | 6 | 3 | 3 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in May 2019, 10 months.
Results were first posted in Feb 2024, 4 years 9 months after primary completion.
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Studies of the drug tested here: RZL-012
Raziel Therapeutics Ltd.