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CompletedNCT04086823Updated Nov 18, 2023Results posted

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 interventional study of RZL-012 and Placebo in Submental Fat, sponsored by Raziel Therapeutics Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Raziel Therapeutics Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Submental Fat
03

In context

Lead sponsor

Raziel Therapeutics Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Men and women 18-65 years old.
  2. Subjects with Body Mass Index \<35
  3. Subjects must have submental skin fold thickness greater than 1.5 cm as measured with calipers.
  4. Males must be willing to be clean shaved for all study visits.
  5. Patient weight must be stable (no fluctuation of >15 pounds in the past year)
  6. 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.
  7. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
  8. Subjects must sign an IRB approved informed consent indicating they are aware of the investigational nature of the study.

Exclusion criteria

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from study participation:

  1. Unable to tolerate subcutaneous injection.
  2. Pregnant or lactating women.
  3. Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
  4. 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
  5. Treatment with botulinum toxin injections in the neck or chin area within 6 months before screening.
  6. Excessive submental skin laxity.
  7. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
  8. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
  9. An active dermatitis or open wound in the proposed treatment area
  10. An active bacterial, fungal, or viral infection in the proposed treatment area
  11. Pre-existing skin condition in the submental region that may confound evaluation or analysis, at investigator discretion
  12. Previously treated with focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate to the submental region within the previous 6 months
  13. Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
  14. 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
  15. Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
  16. Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight.
  17. Subjects with medication or history of coagulopathy.
  18. Allergic subjects to Bendaryl.
  19. Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
  20. Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
  21. Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
  22. Claustrophobia or MRI incompatible device or implant.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    RZL-012

    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)

    Drug: RZL-012

  • Placebo comparator
    Vehicle

    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.

    Drug: Placebo

Interventions

  • DrugRZL-012

    Subcutaneous injection to the submental fat area

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-84 days

Secondary outcomes

  1. Physician's Global Assessment

    Evaluation of treatment efficacy by using Physician's global assessment questionnaire for active vs. placebo subjects, on study Day 84

    Time frame: 0-84 days

  2. 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.

    Time frame: 0-84 days

  3. 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.

    Time frame: 0-84 days

07

Results

Posted Nov 18, 2023

Participant flow

Participant flow — Overall Study
MilestoneRZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2
Started84106
Completed84106
Not completed0000

Outcome measures

PrimarySafety: 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.

Time frame:
0-84 days
Reported as:
Count of participants · Participants
Safety: Adverse Events Follow up
ParticipantsRZL-012 Cohort 1VehicleRZL-012 Cohort 2Vehicle Cohort 2
Safety: Adverse Events Follow up84106
SecondaryPhysician's Global Assessment

Evaluation of treatment efficacy by using Physician's global assessment questionnaire for active vs. placebo subjects, on study Day 84

Time frame:
0-84 days
Reported as:
Count of participants · Participants
Physician's Global Assessment
ParticipantsRZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2
Subjects experienced improvement (Score =0 (completely clear) , 1, 2, 3, Score=4(slight improvement)70100
Subjects that experienced no improvement = Score 5 (no Change)1406
SecondaryEfficacy: 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.

Time frame:
0-84 days
Reported as:
Mean · percentage of volume reduction high dose
Efficacy: MRI Volume Reduction
percentage of volume reduction high doseRZL-012Vehicle
Cohort 2 High Dose (BioClinica Analysis)-12.5 ± 80.7 ± 8.5
Cohort 1 Low Dose (Bioclinica Analysis)-6.4 ± 11-5.7 ± 3
SecondaryEfficacy: 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.

Time frame:
0-84 days
Reported as:
Mean · change in scores on a scale
Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction
change in scores on a scaleRZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2
Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction34.8 ± 10-3.8 ± 29.238.5 ± 25-1.2 ± 16.3

Adverse events

Collected over 84 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RZL-012 Cohort 10/8 (0%)0/8 (0%)8/8 (100%)
Vehicle Cohort 10/4 (0%)0/4 (0%)4/4 (100%)
RZL-012 Cohort 20/10 (0%)0/10 (0%)10/10 (100%)
Vehicle Cohort 20/6 (0%)0/6 (0%)6/6 (100%)
Most frequent other events
Most frequent other events
EventRZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2
Injection site bruisingGeneral disorders5/83/47/103/6
EdemaGeneral disorders4/82/46/103/6
IndurationGeneral disorders4/82/46/103/6
Injection site erythemaGeneral disorders4/82/43/101/6
Injection site painGeneral disorders4/82/44/102/6
Bruising sensationNervous system disorders2/81/40/100/6
PruritusSkin and subcutaneous tissue disorders1/80/40/100/6
Injection site edemaGeneral disorders0/80/41/100/6

Baseline characteristics

Baseline is defined as the last available and evaluable parameter value before and closest to the injection.

Age, Continuous
Age, Continuous(years)RZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2Total
Mean51.6 ± 6.857.5 ± 8.243.3 ± 9.548.8 ± 10.249.65 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)RZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2Total
Female639624
Male21104
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2Total
Hispanic or Latino00112
Not Hispanic or Latino849526
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2Total
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00101
White849627
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)RZL-012 Cohort 1Vehicle Cohort 1RZL-012 Cohort 2Vehicle Cohort 2Total
United States8410628
08

Study locations

1 site
  • DeNova Research
    Chicago, Illinois 60611, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 6, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04086823
Lead sponsor
Raziel Therapeutics Ltd.
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Feb 25, 2020
Primary completion
Sep 16, 2020
Completion
Sep 16, 2020
Results posted
Nov 18, 2023
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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