Submental FatPhase 1/2NCT05466448
An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.
A Phase 1/2 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 that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period. The single treatment session will consist of multiple injections of RZL-012 into the submental area under the chin. 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 15 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.
- If enrolled for Chinese arm, subjects have to be ethnically pure, i.e., Chinese passport holders with all four grandparents being Chinese.
- Has a 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 a visible or large pocket of submental fat- according to physician global assessment.
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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 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))
- 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 the last day of study drug.
- 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.
- 12. 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 uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
- 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.
- 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.
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- 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 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, 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 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 Compare the Pharmacokinetics, Efficacy and Safety of RZL-012 in Chinese Subjects Seeking Submental Fat Reduction vs. Non-Chinese Subjects Seeking Submental Fat Reduction
This is a Phase 2, open label study that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period. The single treatment session will consist of multiple injections of RZL-012 into the submental area under the chin. Blood samples will be collected from all subjects for PK analyses in the first 30 hours after dosing. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Read the detailed description
- 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
Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal dose of 270 mg RZL-012 .
- 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
concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 50mg/ml | Experimental | small synthetic molecule for submental fat reduction Receives: Drug: RZL-012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
Measurement of maximum drug concentration (Cmax) (ng/mL)
Measured: 48 hours
Pharmacokinetics Measure - Area Under the Plasma Concentration Versus Time Curve (AUC) (mg*h/L)
Measured: 48 hours
Secondary outcomes (4)
Efficacy -Change in Score According to Clinician Chin Assessment Tool (C-CAT)
To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Clinician Chin Assessment Tool (C-CAT) by proportion of subjects with reduction in C-CAT score. 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 - Change in Score According to Subject Chin Assessment Tool (S-CAT)
To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Subject Chin Assessment Tool (S-CAT) by proportion of subjects who has reduction in S-CAT score. 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 - Change in Submental Fat Thickness
Change from baseline in submental fat thickness (%), as measured with MRI in RZL-012 treated subjects vs. placebo treated subjects on Day 84 following injection
Measured: 84 days
Safety - Adverse Events Follow up
To evaluate the safety of RZL-012 subcutaneous injections in the submental area in Chinese vs. non Chinese population, as assessed by spontaneous adverse event reports and post injection evaluation of treatment area. Treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus. The number of subjects with treatment-related adverse events will be compared within each treatment group, as assessed by CTCAE v4.0
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 posted20 Jul 2022
- Study start29 Jul 2022
- Primary completion30 May 2023
- Study completion15 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
- 20 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
- NCT05466448
- Sponsor's protocol ID
- RZL-012-SMFC-P2US-001
- Status last verified
- Nov 2023
- First submitted
- 16 Jun 2022
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2 Study to Compare the Pharmacokinetics, Efficacy and Safety of RZL-012 in Chinese Subjects Seeking Submental Fat Reduction vs. Non-Chinese Subjects Seeking Submental Fat Reduction
- ClinicalTrials.gov ID
- NCT05466448
- Acronym / sponsor ID
- RZL-012-SMFC-P2US-001
- Conditions
- Submental Fat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Posted 19 Dec 2023
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 that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period. The single treatment session will consist of multiple injections of RZL-012 into the submental area under the chin. Blood samples will be collected from all subjects for PK analyses in the first 30 hours after dosing. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Detailed description
- 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
Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal dose of 270 mg RZL-012 .
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-012small synthetic molecule for submental fat reduction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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.
- If enrolled for Chinese arm, subjects have to be ethnically pure, i.e., Chinese passport holders with all four grandparents being Chinese.
- Has a 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.
Key exclusion criteria (24 listed)
- Is unable to tolerate subcutaneous injections.
- Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- Has any uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
- 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.
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-012concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012 | Drug | RZL-012 50mg/ml |
Primary outcome
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
Time frame: 48 hours
Measurement of maximum drug concentration (Cmax) (ng/mL)
Pharmacokinetics Measure - Area Under the Plasma Concentration Versus Time Curve (AUC) (mg*h/L)
Time frame: 48 hours
4 secondary outcomes
Efficacy -Change in Score According to Clinician Chin Assessment Tool (C-CAT)
Time frame: 84 days
Efficacy - Change in Score According to Subject Chin Assessment Tool (S-CAT)
Time frame: 84 days
Efficacy - Change in Submental Fat Thickness
Time frame: 84 days
Safety - Adverse Events Follow up
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 19 Dec 2023.
- 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 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 15 inclusion and 24 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 19 Dec 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 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 19 Dec 2023). 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?
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 19 Dec 2023.