Submental FatPhase 1/2NCT05476679
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
A Phase 1/2 study testing RZL-012, RZL-012+Lidacaine injection prior treatment and RZL-012+Medrol in people with Submental Fat, run by Raziel Therapeutics Ltd. at 1 site in United States.
Trial summary
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments: Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Submental Fat
- What is being tested?
- RZL-012, RZL-012+Lidacaine injection prior treatment and RZL-012+Medrol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2022to 12 Jun 2023
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) between >22 kg/m2 and <40 kg/m2.
- Has SMF bulge that is contiguous and fits to 32±4 injections sites according to a grid with 1 centimeter (cm) distance between injection points.
- Has grade 3 to 4 of SMF as rated by both the C-CAT and S-CAT.
- Has stable weight, with no fluctuation of >5 kg in the past 12 months.
- If female, is not pregnant or breastfeeding based on the following:
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- agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 4 weeks after the last day of study drug and a negative serum pregnancy test (ß-hCG) at screening and negative urine pregnancy test at baseline; or
- is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or
- is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause and documented serum follicle-stimulating hormone (FSH) level > 40 mIU/mL or another documented medical condition (e.g., was born without a uterus)) NOTE: The following are considered highly effective contraceptive methods: hormonal oral contraceptives, injectables, and patches; intrauterine devices; double-barrier methods (synthetic condom, diaphragm, or cervical cap used with spermicidal foam, cream, or gel); and male partner sterilization.
- If male (with or without vasectomy), agree to the use of highly effective contraceptive methods as listed above in criteria 7 as well as to use a barrier method, e.g. condom , from study check-in until 7 days after drug injection.
- Is willing to avoid strenuous exercise for seven (7) days post treatment.
- Is able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Is willing and able to sign an Institutional Review Board (IRB) approved informed consent form (ICF) indicating that they are aware of the investigational nature of the study.
Who cannot join
- Is unable to tolerate subcutaneous injections.
- Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- Has any systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease.
- Has any contraindications to oral corticosteroids (prednisone), NSAIDs (e.g., Celecoxib) or non-sedative antihistamines (e.g. Zyrtec)
- Has skin laxity (i.e., elastosis, skin crepiness, skin redundancy, skin draping, vertical and/or horizontal skin bands and folds, blunting of cervical mental angle, loss of opposition of skin to underlying neck structures due to skin laxity) that could obscure the evaluation and treatment of SMF.
- Has any scars, unshaven hair, tattoos, facial hair or jewelry on or near the proposed treatment area.
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- Has presence of structures or confounding factors that may interfere with assessing SMF such as but not limited to enlarged submandibular salivary and/or parotid glands, micrognanthia, chin implant, soft tissue volume augmentation of chin and/or jawline, pronounced platysmal bands and deep necklace lines or presence of facial jowls that could obscure the evaluation of SMF.
- Has a fat bulge under the chin that is too large to be adequately treated by 32±4 contiguous injections on a 1cm grid .
- Has a fat bulge under the chin that is of an insufficient volume to allow 32±4 injections within a contiguous 1 cm grid.
- Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
- Has an active bacterial, fungal, or viral infection in the proposed treatment area.
- Has a pre-existing skin condition in the submental region that, at the Investigator's discretion, may confound evaluation or analysis.
- Has previously had treatments or surgery in the submentum, such as but not limited to, focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate, or neck lift.
- Has pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia, or facial nerve palsy.
- Has Dercum's Disease.
- Has allergic reactions to injectables
- Has allergic reactions to Zyrtec or Celecoxib.
- Has any pre-existing medical condition other than increased SMF that, at the Investigator's discretion, may result in increased submental fullness, such as but not limited to, thyroid enlargement, goiter, cervical lymphadenopathy, etc.
- Has a planned fat reduction procedure of any variety to the submental region for the duration of the study.
- Has medication or a history of coagulopathy.
- Has a history or family history of venous thrombotic disease.
- Has been treated chronically at least three (3) months prior to study entry with systemic steroids or immunosuppressive drugs.
- Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs)
- Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen/Celecoxib, warfarin, vitamins, and herbal preparations) for seven (7) days prior to treatment.
- .Has had treatment with botulinum toxin injections in the neck or chin area within nine (9) months prior to screening.
- Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase 2 Study to Evaluate the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
Read the detailed description
In the first stage of the study, 5 subjects will be randomized into each of the treatment groups. Study outcomes will be assessed up to one week thereafter to determine the need to modify additional study treatments. Subsequently up to 10 additional subjects will be randomized into each of the treatment groups for the second stage of the study.
For each subject, the study will consist of a screening period, baseline period in which subjects will receive a single treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Each subject will be treated with the same dose of RZL-012 :
- RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012, Each subject will receive additional study treatments in accordance with the treatment group to which the subject is randomized.
- Conditions
- Submental Fat
- Being tested
- RZL-012, RZL-012+Lidacaine injection prior treatment, RZL-012+Medrol, RZL-012+Celecoxib+Zyrtec, RZL-012+facial and neck wrap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZL-012Drug
50mg/ml drug formulation
RZL-012+Lidacaine injection prior treatmentDrug
5ml lidocaine will be injected 10 minutes before RZL-012 treatment
RZL-012+MedrolDrug
oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
RZL-012+Celecoxib+ZyrtecDrug
200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
RZL-012+facial and neck wrapDrug
Universal Facial Band
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 50mg/ml | Experimental | Not described Receives: Drug: RZL-012; Drug: RZL-012+Lidacaine injection prior treatment; Drug: RZL-012+Medrol; Drug: RZL-012+Celecoxib+Zyrtec; Drug: RZL-012+facial and neck wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events Follow up
Number of subjects with severe swelling in each subgroup
Measured: 84 days
Secondary outcomes (3)
Efficacy -Reduction in Score According to Clinician Chin Assessment Tool (C-CAT)
Number of subjects who has at least 1 grade improvement in C-CAT. The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck
Measured: 84 days
Efficacy - Number of Participants With 1 Grade Improvement According to the Subject Chin Assessment Tool (S-CAT)
To determine the efficacy of RZL-012 vs. RZL-012 with additional treatments on Day 84 versus baseline using the Subject Chin Assessment Tool (S-CAT). The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck
Measured: 84 days
Efficacy - Percentage of Change From Baseline in Submental Fat Volume
Percentage of change from baseline in submental fat volume , as measured with MRI in RZL-012 vs. RZL+other treatments treated subjects vs. placebo treated subjects on Day 84 following injection.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start25 Sep 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
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 Submental FatStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raziel Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476679
- Sponsor's protocol ID
- RZL-012-SMF-SWMTG-001
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 30 Jan 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2 Study to Evaluate the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events
- ClinicalTrials.gov ID
- NCT05476679
- Acronym / sponsor ID
- RZL-012-SMF-SWMTG-001
- Conditions
- Submental Fat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Posted 30 Jan 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 a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
Detailed description
In the first stage of the study, 5 subjects will be randomized into each of the treatment groups. Study outcomes will be assessed up to one week thereafter to determine the need to modify additional study treatments. Subsequently up to 10 additional subjects will be randomized into each of the treatment groups for the second stage of the study.
For each subject, the study will consist of a screening period, baseline period in which subjects will receive a single treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Each subject will be treated with the same dose of RZL-012 :
- RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012, Each subject will receive additional study treatments in accordance with the treatment group to which the subject is randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RZL-012 50mg/ml | Experimental | Drug: RZL-012, Drug: RZL-012+Lidacaine injection prior treatment, Drug: RZL-012+Medrol, Drug: RZL-012+Celecoxib+Zyrtec, Drug: RZL-012+facial and neck wrap |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) between >22 kg/m2 and <40 kg/m2.
- Has SMF bulge that is contiguous and fits to 32±4 injections sites according to a grid with 1 centimeter (cm) distance between injection points.
- Has grade 3 to 4 of SMF as rated by both the C-CAT and S-CAT.
- Has stable weight, with no fluctuation of >5 kg in the past 12 months.
Key exclusion criteria (26 listed)
- Is unable to tolerate subcutaneous injections.
- Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- Has any systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease.
- Has any contraindications to oral corticosteroids (prednisone), NSAIDs (e.g., Celecoxib) or non-sedative antihistamines (e.g. Zyrtec)
- Has skin laxity (i.e., elastosis, skin crepiness, skin redundancy, skin draping, vertical and/or horizontal skin bands and folds, blunting of cervical mental angle, loss of opposition of skin to underlying neck structures due to skin laxity) that could obscure the evaluation and treatment of SMF.
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-01250mg/ml drug formulation | Drug | RZL-012 50mg/ml |
| RZL-012+Lidacaine injection prior treatment5ml lidocaine will be injected 10 minutes before RZL-012 treatment | Drug | RZL-012 50mg/ml |
| RZL-012+Medroloral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use | Drug | RZL-012 50mg/ml |
| RZL-012+Celecoxib+Zyrtec200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6 | Drug | RZL-012 50mg/ml |
| RZL-012+facial and neck wrapUniversal Facial Band | Drug | RZL-012 50mg/ml |
Primary outcome
Safety - Adverse Events Follow up
Time frame: 84 days
Number of subjects with severe swelling in each subgroup
3 secondary outcomes
Efficacy -Reduction in Score According to Clinician Chin Assessment Tool (C-CAT)
Time frame: 84 days
Efficacy - Number of Participants With 1 Grade Improvement According to the Subject Chin Assessment Tool (S-CAT)
Time frame: 84 days
Efficacy - Percentage of Change From Baseline in Submental Fat Volume
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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 1/2 study testing RZL-012, RZL-012+Lidacaine injection prior treatment and RZL-012+Medrol in people with Submental Fat, 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 13 inclusion and 26 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 30 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Jan 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?
Safety - Adverse Events Follow up (time frame: 84 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 30 Jan 2024.