Submental FatPhase 2NCT04867434
Efficacy and Safety of RZL-012 on Submental Fat Reduction
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
A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days. 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?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 31 May 2022
- 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 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 and <40.
- Has SMF area that is contiguous and fits to 32±4 injections sites according to a grid with 1 cm distance between injection points.
- Has moderate to severe grade 3 to 4 of SMF as rated by the C-SFS.
- Has moderate to severe grade 3 to 4 of SMF as rated by the P-SFS.
- Has stable weight, with no fluctuation of >5 kg in the past 12 months.
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- 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 7 days 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 in Criterion #7 above) 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.
- 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.
- 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 had treatment with botulinum toxin injections in the neck or chin area within nine (9) months prior to screening.
- Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.
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- 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 an extreme fat bulge under the chin and the submental fat was previously rated as 'very severe'.
- Has fat extends down the neck beyond the Adam's Apple, towards the base of the neck where the fat extends laterally along the jawline making the jawline indistinguishable from the neck.
- 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.
- 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 dermatitis or open wound in the proposed treatment area.
- Has abnormal coagulation tests (PT, PTT)
- Has D-dimer value >0.64mg/L in screening visit
- 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 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).
- Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study.
- Has claustrophobia or an MRI incompatible device or implant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Three Arm, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of RZL-012 in Subjects Seeking for Submental Fat Reduction
A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days.
Read the detailed description
Each subject will be randomized to either active treatment (high or low dose RZL-012) or placebo at a ratio of 1:1:1 per group and receive one of the following:
- low dose (concentration of injected solution 34 mg/mL RZL-012) of 5.1 mg/0.15 mL/injection point that results in a dose/volume of 163.2±20.4 mg/4.8±0.6 mL RZL-012,
- high dose (concentration of injected solution 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,
- placebo of 0.15 mL/injection point that results in a total maximum volume of 4.8±0.6 mL.
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 doses of 183.6 mg and 270 mg for the low and high doses, respectively. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose or 7.5 mg for the high dose in a volume of 0.15 mL/injection site. Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL.
- Conditions
- Submental Fat
- Being tested
- RZL-012, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZL-012Drug
small synthetic molecule for submental fat reduction
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 50mg/ml | Active comparator | 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 doses 270 mg for the high doses. Each injection point will be dosed with 7.5 mg for the high dose in a volume of 0.15 mL/injection site. Receives: Drug: RZL-012 |
| RZL-012 34mg/ml | Active comparator | 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 doses of 183.6 mg for the low dose. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose in a volume of 0.15 mL/injection site. Receives: Drug: RZL-012 |
| Placebo | Placebo comparator | Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84
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). 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
Secondary outcomes (3)
Efficacy - the Proportion of Subjects With at Least 1-grade Improvement in 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). 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 - Relative Change in Submental Fat Volume on Day 84 vs. Baseline
Percent reduction from baseline in submental fat volume , as measured with MRI in RZL-012 treated subjects vs. placebo treated subjects on Day 84 following injection vs. baseline.
Measured: 84 days
Safety - Adverse Events Follow up
To evaluate the safety of RZL-012 subcutaneous injections in the submental area, relative to placebo, 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 posted30 Apr 2021
- Study start15 Jun 2021
- Primary completion20 Apr 2022
- Study completion31 May 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raziel Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raceli Gueta, PhD, Study director, Raziel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867434
- Sponsor's protocol ID
- RZL-012-SMF-P2b-US-001
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 28 Sep 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Three Arm, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of RZL-012 in Subjects Seeking for Submental Fat Reduction
- ClinicalTrials.gov ID
- NCT04867434
- Acronym / sponsor ID
- RZL-012-SMF-P2b-US-001
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days.
Detailed description
Each subject will be randomized to either active treatment (high or low dose RZL-012) or placebo at a ratio of 1:1:1 per group and receive one of the following:
- low dose (concentration of injected solution 34 mg/mL RZL-012) of 5.1 mg/0.15 mL/injection point that results in a dose/volume of 163.2±20.4 mg/4.8±0.6 mL RZL-012,
- high dose (concentration of injected solution 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,
- placebo of 0.15 mL/injection point that results in a total maximum volume of 4.8±0.6 mL.
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 doses of 183.6 mg and 270 mg for the low and high doses, respectively. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose or 7.5 mg for the high dose in a volume of 0.15 mL/injection site. Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RZL-012 50mg/ml | Active comparator | Drug: RZL-012Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses 270 mg for the high doses. Each injection point will be dosed with 7.5 mg for the high dose in a volume of 0.15 mL/injection site. |
| RZL-012 34mg/ml | Active comparator | Drug: RZL-012Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses of 183.6 mg for the low dose. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose in a volume of 0.15 mL/injection site. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) between >22 and <40.
- Has SMF area that is contiguous and fits to 32±4 injections sites according to a grid with 1 cm distance between injection points.
- Has moderate to severe grade 3 to 4 of SMF as rated by the C-SFS.
- Has moderate to severe grade 3 to 4 of SMF as rated by the P-SFS.
Key exclusion criteria (28 listed)
- Subjects must NOT meet any of the following Exclusion criteria to be eligible for enrollment:
- 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 had treatment with botulinum toxin injections in the neck or chin area within nine (9) months prior to screening.
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-012small synthetic molecule for submental fat reduction | Drug | RZL-012 34mg/ml, RZL-012 50mg/ml |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84
Time frame: 84 days
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). 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
3 secondary outcomes
Efficacy - the Proportion of Subjects With at Least 1-grade Improvement in Subject Chin Assessment Tool (S-CAT)
Time frame: 84 days
Efficacy - Relative Change in Submental Fat Volume on Day 84 vs. Baseline
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 28 Sep 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.
Raceli Gueta, PhD study director
Raziel Therapeutics
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 14 inclusion and 28 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 28 Sep 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. Some participants in this study may receive a placebo. 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 28 Sep 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?
Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84 (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 28 Sep 2023.