Submental FatPhase 2NCT04086823
A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.
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
Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012. The total of 28 subjects will be enrolled in 2 clinical sites. 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 16 Sep 2020
- 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
- Men and women 18-65 years old.
- Subjects with Body Mass Index <35
- Subjects must have submental skin fold thickness greater than 1.5 cm as measured with calipers.
- Males must be willing to be clean shaved for all study visits.
- Patient weight must be stable (no fluctuation of >15 pounds in the past year)
- Males or females in the age of fertility agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects must sign an IRB approved informed consent indicating they are aware of the investigational nature of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from study participation:
- Unable to tolerate subcutaneous injection.
- Pregnant or lactating women.
- Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
- Any uncontrolled systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Treatment with botulinum toxin injections in the neck or chin area within 6 months before screening.
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- Excessive submental skin laxity.
- Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- An active dermatitis or open wound in the proposed treatment area
- An active bacterial, fungal, or viral infection in the proposed treatment area
- Pre-existing skin condition in the submental region that may confound evaluation or analysis, at investigator discretion
- Previously treated with focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate to the submental region within the previous 6 months
- Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
- Pre-existing medical condition other than increased submental fat that may result in increased submental fullness such as but not limited to thyroid enlargement, goiter, cervical lymphadenopathy etc., at investigator discretion
- Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
- Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight.
- Subjects with medication or history of coagulopathy.
- Allergic subjects to Bendaryl.
- Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
- Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
- Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
- Claustrophobia or MRI incompatible device or implant.
Trial locations and contacts
1 site in 1 country.
About this study
Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012. The total of 28 subjects will be enrolled in 2 clinical sites.
Read the detailed description
This is a single blinded, randomized, placebo-controlled, 2-cohort clinical study in healthy volunteers. Cohort 1 will be comprised of 8 active (RZL-012) and 4 placebo subjects. Cohort 2 will be comprised of 16 subjects wuth at least 4 placebo subjects. All subjects will receive a single dose of RZL-012 or vehicle into the submental area, after which they will be monitored for safety and efficacy during 84 days of follow-up.
Subjects will be blinded to study treatment while physicians will not be blinded.
The study will be composed of 2 treatment cohorts, 12 in cohort 1 and 16 in cohort 2.
The study will be conducted in 2 clinical sites. Per each study cohort, subjects will be randomized to receive active or placebo treatment according to a randomization program that will be prepared prior to study initiation. Each clinical site will have at least one active and one placebo treatment subject per each study cohorts. In case of slow enrollment in one of the sites, other sites may complete the enrollment of subjects in each cohort.
Cohort 1 (N=12) - Each subject will be dosed with up to 120 mg RZL-012 (depending on submental fat area) or vehicle.
Cohort 2 (N=16) - Each subject will be dosed with up to 240 mg RZL-012 (depending on submental fat area) or vehicle.
Treatment of cohort 2 will start following cohort 1 day 28 data. An independent Data Safety Monitoring Board (DSMB) will review safety and tolerability data for cohort 1 subjects, 28 days after injection, and decide whether it is safe to increase the dose for the next study cohort. The decision to proceed to the cohort 2 will be made within 30 days (28 days + 2 days) after injection of the last dosed subject in cohort 1.
The DSMB will be comprised of two independent MDs with expertise in the aesthetic area and in conduction of clinical trials.
In case of serious safety concerns (e.g. prolonged severe swelling or severe pain following injection) among cohort 1 subjects receiving the 120mg dose, sponsor and DSMB may decide to reduce or stay with the 120mg/subject dose level for cohort 2 subjects.
- 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
Subcutaneous injection to the submental fat area
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 | Active comparator | A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05/0.1mL per site):
1. Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
2. Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL) Receives: Drug: RZL-012 |
| Vehicle | Placebo comparator | Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05/0.1mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 subjects. Specifically, Pain, Induration, Bruising, Erythema and Edema will be closely followed up following treatment.
Measured: 0-84 days
Secondary outcomes (3)
Physician's Global Assessment
Evaluation of treatment efficacy by using Physician's global assessment questionnaire for active vs. placebo subjects, on study Day 84
Measured: 0-84 days
Efficacy: MRI Volume Reduction
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.
Measured: 0-84 days
Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction
Improvement from baseline in the Faceq satisfaction questionnaire rating score in RZL-012 treated subjects vs. placebo treated subjects on day 84.
Measured: 0-84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start25 Feb 2020
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 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
- NCT04086823
- Sponsor's protocol ID
- RZL-012-SMF-P2aUS-001
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04086823
- Acronym / sponsor ID
- RZL-012-SMF-P2aUS-001
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012. The total of 28 subjects will be enrolled in 2 clinical sites.
Detailed description
This is a single blinded, randomized, placebo-controlled, 2-cohort clinical study in healthy volunteers. Cohort 1 will be comprised of 8 active (RZL-012) and 4 placebo subjects. Cohort 2 will be comprised of 16 subjects wuth at least 4 placebo subjects. All subjects will receive a single dose of RZL-012 or vehicle into the submental area, after which they will be monitored for safety and efficacy during 84 days of follow-up.
Subjects will be blinded to study treatment while physicians will not be blinded.
The study will be composed of 2 treatment cohorts, 12 in cohort 1 and 16 in cohort 2.
The study will be conducted in 2 clinical sites. Per each study cohort, subjects will be randomized to receive active or placebo treatment according to a randomization program that will be prepared prior to study initiation. Each clinical site will have at least one active and one placebo treatment subject per each study cohorts. In case of slow enrollment in one of the sites, other sites may complete the enrollment of subjects in each cohort.
Cohort 1 (N=12) - Each subject will be dosed with up to 120 mg RZL-012 (depending on submental fat area) or vehicle.
Cohort 2 (N=16) - Each subject will be dosed with up to 240 mg RZL-012 (depending on submental fat area) or vehicle.
Treatment of cohort 2 will start following cohort 1 day 28 data. An independent Data Safety Monitoring Board (DSMB) will review safety and tolerability data for cohort 1 subjects, 28 days after injection, and decide whether it is safe to increase the dose for the next study cohort. The decision to proceed to the cohort 2 will be made within 30 days (28 days + 2 days) after injection of the last dosed subject in cohort 1.
The DSMB will be comprised of two independent MDs with expertise in the aesthetic area and in conduction of clinical trials.
In case of serious safety concerns (e.g. prolonged severe swelling or severe pain following injection) among cohort 1 subjects receiving the 120mg dose, sponsor and DSMB may decide to reduce or stay with the 120mg/subject dose level for cohort 2 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RZL-012 | Active comparator | Drug: RZL-012A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05/0.1mL per site): 1. Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL) 2. Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL) |
| Vehicle | Placebo comparator | Drug: PlaceboSubject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05/0.1mL per site) into the submental fat. Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1. Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women 18-65 years old.
- Subjects with Body Mass Index <35
- Subjects must have submental skin fold thickness greater than 1.5 cm as measured with calipers.
- Males must be willing to be clean shaved for all study visits.
- Patient weight must be stable (no fluctuation of >15 pounds in the past year)
Key exclusion criteria (23 listed)
- Unable to tolerate subcutaneous injection.
- Pregnant or lactating women.
- Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
- Any uncontrolled systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Treatment with botulinum toxin injections in the neck or chin area within 6 months before 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-012Subcutaneous injection to the submental fat area | Drug | RZL-012 |
| PlaceboPlacebo | Drug | Vehicle |
Primary outcome
Safety: Adverse Events Follow up
Time frame: 0-84 days
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 subjects. Specifically, Pain, Induration, Bruising, Erythema and Edema will be closely followed up following treatment.
3 secondary outcomes
Physician's Global Assessment
Time frame: 0-84 days
Efficacy: MRI Volume Reduction
Time frame: 0-84 days
Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction
Time frame: 0-84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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 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 8 inclusion and 23 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. 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 18 Nov 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?
Safety: Adverse Events Follow up (time frame: 0-84 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.