Trial Outcomes & Findings for 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. (NCT NCT04086823)
NCT ID: NCT04086823
Last Updated: 2023-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
0-84 days
Results posted on
2023-11-18
Participant Flow
The safety and efficacy of exposed subjects to RZL-012 were compared to exposed subjects with placebo
Participant milestones
| Measure |
RZL-012 Cohort 1
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL 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)
|
Vehicle Cohort 1
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle Cohort 2
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
10
|
6
|
|
Overall Study
COMPLETED
|
8
|
4
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
RZL-012 Cohort 1
n=8 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle Cohort 1
n=4 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total .of 2.4 mL will be injected for placebo subjects enrolled during cohort 2.
Placebo: Placebo
|
RZL-012 Cohort 2
n=10 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle Cohort 2
n=6 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
Placebo: Placebo
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
57.5 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
48.8 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
49.65 years
STANDARD_DEVIATION 9.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 0-84 daysPopulation: Safety Analysis consist of all enrolled subjects who received the study treatment, (exposed population), vs. placebo treated subjects.
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.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=8 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle
n=4 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
n=10 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
|
Vehicle Cohort 2
n=6 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
Safety: Adverse Events Follow up
|
8 Participants
|
4 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0-84 daysPopulation: Subjects were analysed according to the treatment received.
Evaluation of treatment efficacy by using Physician's global assessment questionnaire for active vs. placebo subjects, on study Day 84
Outcome measures
| Measure |
RZL-012 Cohort 1
n=8 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle
n=4 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
n=10 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
|
Vehicle Cohort 2
n=6 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
Physician's Global Assessment
Subjects experienced improvement (Score =0 (completely clear) , 1, 2, 3, Score=4(slight improvement)
|
7 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
|
Physician's Global Assessment
Subjects that experienced no improvement = Score 5 (no Change)
|
1 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0-84 daysPopulation: The efficacy in the MRI was divided to per treated doses cohorts
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.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=18 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle
n=10 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
|
Vehicle Cohort 2
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
Efficacy: MRI Volume Reduction
Cohort 2 High Dose (BioClinica Analysis)
|
-12.5 percentage of volume reduction high dose
Standard Deviation 8
|
0.7 percentage of volume reduction high dose
Standard Deviation 8.5
|
—
|
—
|
|
Efficacy: MRI Volume Reduction
Cohort 1 Low Dose (Bioclinica Analysis)
|
-6.4 percentage of volume reduction high dose
Standard Deviation 11
|
-5.7 percentage of volume reduction high dose
Standard Deviation 3
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-84 daysPopulation: The questionnaire efficacy included all exposed population to RZL-012 vs. all treated subjects by placebo
Improvement from baseline in the Faceq satisfaction questionnaire rating score in RZL-012 treated subjects vs. placebo treated subjects on day 84.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=8 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle
n=4 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
n=10 Participants
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
|
Vehicle Cohort 2
n=6 Participants
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction
|
34.8 change in scores on a scale
Standard Deviation 10
|
-3.8 change in scores on a scale
Standard Deviation 29.2
|
38.5 change in scores on a scale
Standard Deviation 25
|
-1.2 change in scores on a scale
Standard Deviation 16.3
|
Adverse Events
RZL-012 Cohort 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
RZL-012 Cohort 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RZL-012 Cohort 1
n=8 participants at risk
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05mL per site):
Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL)
RZL-012: Subcutaneous injection to the submental fat area
|
Vehicle Cohort 1
n=4 participants at risk
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05mL per site) into the submental fat.
Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1.
Placebo: Placebo
|
RZL-012 Cohort 2
n=10 participants at risk
A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.1mL per site):
Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)
|
Vehicle Cohort 2
n=6 participants at risk
Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.1mL per site) into the submental fat.
Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.
|
|---|---|---|---|---|
|
General disorders
Edema
|
50.0%
4/8 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
2/4 • 84 days
All reported adverse events were related to injection site condition.
|
60.0%
6/10 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
3/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
General disorders
Induration
|
50.0%
4/8 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
2/4 • 84 days
All reported adverse events were related to injection site condition.
|
60.0%
6/10 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
3/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
General disorders
Injection site bruising
|
62.5%
5/8 • 84 days
All reported adverse events were related to injection site condition.
|
75.0%
3/4 • 84 days
All reported adverse events were related to injection site condition.
|
70.0%
7/10 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
3/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
General disorders
Injection site erythema
|
50.0%
4/8 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
2/4 • 84 days
All reported adverse events were related to injection site condition.
|
30.0%
3/10 • 84 days
All reported adverse events were related to injection site condition.
|
16.7%
1/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
General disorders
Injection site edema
|
0.00%
0/8 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/4 • 84 days
All reported adverse events were related to injection site condition.
|
10.0%
1/10 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
General disorders
Injection site pain
|
50.0%
4/8 • 84 days
All reported adverse events were related to injection site condition.
|
50.0%
2/4 • 84 days
All reported adverse events were related to injection site condition.
|
40.0%
4/10 • 84 days
All reported adverse events were related to injection site condition.
|
33.3%
2/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
Nervous system disorders
Bruising sensation
|
25.0%
2/8 • 84 days
All reported adverse events were related to injection site condition.
|
25.0%
1/4 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/10 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/6 • 84 days
All reported adverse events were related to injection site condition.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/4 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/10 • 84 days
All reported adverse events were related to injection site condition.
|
0.00%
0/6 • 84 days
All reported adverse events were related to injection site condition.
|
Additional Information
Racheli Gueta , Director of Clinical trials
Raziel Therapeutics
Phone: 97289124670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place