Submental FatPhase 2NCT05763160
An Open-label Study That Will Test a Second Treatment Session of RZL-012.
A Phase 2 study testing RZL-012 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 study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2023to 20 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- For a subject to be eligible for this study, he or she must meet all of the following criteria:
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 and whose current C-CAT score is 2, 3 or 4
- Who successfully completed (as in completed the day 84 visit) the RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies.
- Has body mass index (BMI) between >22 kg/m2 and <40 kg/m2.
- Has SMF bulge that is contiguous and can receive between 16 to 36 injections distanced 1 centimeter (cm) from each other according to the injection grid.
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- 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:
- 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 abstaining
- 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 or 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.
- Can 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
- Subjects must NOT meet any of the following Exclusion criteria to be eligible for enrollment:
- Is unable to tolerate subcutaneous injections.
- Any subject who had any treatment related SAE's or allergic reactions to treatment in the previous RZL-012 studies.
- Has any systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease, regardless of whether the condition is controlled with medication.
- 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, micrognathia, 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 36 contiguous injections on a 1cm grid .
- Has a fat bulge under the chin that is of an insufficient volume to allow 16 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 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 Safety and Efficacy of a Second Treatment Session of RZL-012 Into Submental Fat in Subjects Seeking Further Improvement
This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012.
The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial.
For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second 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.
Read the detailed description
Screening Period:
Subjects will be eligible to undergo screening after successful completion of (defined as completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the screening period, subjects will be assessed for study eligibility by evaluation of subjects' SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography.
Day 0/Baseline:
Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be recorded. Subjects will be asked about their pain levels using VAS.
Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7, 28, 56 and 84 for efficacy and safety assessments.
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded.
- Conditions
- Submental Fat
- Being tested
- RZL-012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZL-012Drug
Ready to use drug product for injection into the subcutaneous fat
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 50mg/ml | Experimental | Not described Receives: Drug: RZL-012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse events follow up
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded
Measured: 84 days
Secondary outcomes (1)
Efficacy -Change in score according to Clinician chin assessment tool (C-CAT)
- Proportion of subjects who have at least a 1-grade improvement in C-CAT on Day 84 versus baseline in subjects receiving a second treatment session of RZL-012. Baseline is defined as the C-CAT assessment made immediately prior to the second treatment session
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 posted10 Mar 2023
- Study start29 May 2023
- Primary completion30 Jul 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Second injection session of RZL-012 will be administered to subjects who previously treated with RZL-012 in submental fat
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT05763160
- Sponsor's protocol ID
- RZL-012-SMF-2nd-P2US-001
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of a Second Treatment Session of RZL-012 Into Submental Fat in Subjects Seeking Further Improvement
- ClinicalTrials.gov ID
- NCT05763160
- Acronym / sponsor ID
- RZL-012-SMF-2nd-P2US-001
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
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 study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012.
The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial.
For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second 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.
Detailed description
Screening Period:
Subjects will be eligible to undergo screening after successful completion of (defined as completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the screening period, subjects will be assessed for study eligibility by evaluation of subjects' SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography.
Day 0/Baseline:
Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be recorded. Subjects will be asked about their pain levels using VAS.
Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7, 28, 56 and 84 for efficacy and safety assessments.
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Second injection session of RZL-012 will be administered to subjects who previously treated with RZL-012 in submental fat
| Arm | Type | Receives |
|---|---|---|
| RZL-012 50mg/ml | Experimental | Drug: RZL-012 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For a subject to be eligible for this study, he or she must meet all of the following criteria:
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 and whose current C-CAT score is 2, 3 or 4
- Who successfully completed (as in completed the day 84 visit) the RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies.
- Has body mass index (BMI) between >22 kg/m2 and <40 kg/m2.
Key exclusion criteria (25 listed)
- Subjects must NOT meet any of the following Exclusion criteria to be eligible for enrollment:
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-012Ready to use drug product for injection into the subcutaneous fat | Drug | RZL-012 50mg/ml |
Primary outcome
Safety - Adverse events follow up
Time frame: 84 days
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded
1 secondary outcome
Efficacy -Change in score according to Clinician chin assessment tool (C-CAT)
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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 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 16 inclusion and 25 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 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 18 Nov 2023.