Trial Outcomes & Findings for Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events (NCT NCT05476679)
NCT ID: NCT05476679
Last Updated: 2024-01-30
Results Overview
Number of subjects with severe swelling in each subgroup
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
84 days
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
RZL-012 50mg/ml
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Medrol
RZL-012+Medrol: oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
9
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
RZL-012 50mg/ml
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Medrol
RZL-012+Medrol: oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
Baseline characteristics by cohort
| Measure |
RZL-012 50mg/ml
n=8 Participants
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine
n=10 Participants
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Medrol
n=9 Participants
RZL-012+Medrol: oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=11 Participants
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 Participants
RZL-012+facial and neck wrap: Universal Facial Band
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 Years
STANDARD_DEVIATION 7.2 • n=39 Participants
|
51.1 Years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
49.8 Years
STANDARD_DEVIATION 6.5 • n=35 Participants
|
44 Years
STANDARD_DEVIATION 9.5 • n=31 Participants
|
36.8 Years
STANDARD_DEVIATION 5.7 • n=146 Participants
|
45.9 Years
STANDARD_DEVIATION 9.1 • n=19 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
42 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
47 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
11 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
34 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
10 participants
n=41 Participants
|
9 participants
n=35 Participants
|
11 participants
n=31 Participants
|
10 participants
n=146 Participants
|
48 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 84 daysNumber of subjects with severe swelling in each subgroup
Outcome measures
| Measure |
RZL-012 50mg/ml
n=8 Participants
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=10 Participants
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=9 Participants
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=11 Participants
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 Participants
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Safety - Adverse Events Follow up
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 84 daysNumber of subjects who has at least 1 grade improvement in 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
Outcome measures
| Measure |
RZL-012 50mg/ml
n=8 Participants
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=10 Participants
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=9 Participants
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=9 Participants
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 Participants
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Efficacy -Reduction in Score According to Clinician Chin Assessment Tool (C-CAT)
|
6 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 84 daysTo determine the efficacy of RZL-012 vs. RZL-012 with additional treatments 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
Outcome measures
| Measure |
RZL-012 50mg/ml
n=8 Participants
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=10 Participants
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=9 Participants
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=9 Participants
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 Participants
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Efficacy - Number of Participants With 1 Grade Improvement According to the Subject Chin Assessment Tool (S-CAT)
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 84 daysPopulation: There were only 33/46 subjects that had an MRI scan.
Percentage of change from baseline in submental fat volume , as measured with MRI in RZL-012 vs. RZL+other treatments treated subjects vs. placebo treated subjects on Day 84 following injection.
Outcome measures
| Measure |
RZL-012 50mg/ml
n=6 Participants
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=6 Participants
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=7 Participants
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=8 Participants
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=6 Participants
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Efficacy - Percentage of Change From Baseline in Submental Fat Volume
|
-7.1 percentage of change from baseline
Standard Deviation 6.0
|
-15.4 percentage of change from baseline
Standard Deviation 10.2
|
-17.0 percentage of change from baseline
Standard Deviation 12.9
|
-10.8 percentage of change from baseline
Standard Deviation 9.8
|
-14.8 percentage of change from baseline
Standard Deviation 7.6
|
Adverse Events
RZL-012 50mg/ml
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
RZL-012+Lidacaine Injection Prior Treatment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
RZL-012+Methylprednisolone (Medrol)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
RZL-012+Celecoxib+Zyrtec
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
RZL-012+Facial and Neck Wrap
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RZL-012 50mg/ml
n=8 participants at risk
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=10 participants at risk
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=9 participants at risk
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=11 participants at risk
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 participants at risk
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Investigations
Hepatic mass, Liver function test increase
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
9.1%
1/11 • Number of events 2 • 3 months
|
0.00%
0/10 • 3 months
|
Other adverse events
| Measure |
RZL-012 50mg/ml
n=8 participants at risk
RZL-012: 50mg/ml drug formulation
|
RZL-012+Lidacaine Injection Prior Treatment
n=10 participants at risk
RZL-012+Lidacaine injection prior treatment: 5ml lidocaine will be injected 10 minutes before RZL-012 treatment
|
RZL-012+Methylprednisolone (Medrol)
n=9 participants at risk
RZL-012+methylprednisolone (Medrol): oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
|
RZL-012+Celecoxib+Zyrtec
n=11 participants at risk
RZL-012+Celecoxib+Zyrtec: 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
|
RZL-012+Facial and Neck Wrap
n=10 participants at risk
RZL-012+facial and neck wrap: Universal Facial Band
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/8 • 3 months
|
10.0%
1/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
0.00%
0/10 • 3 months
|
|
General disorders
Injection site bruising
|
12.5%
1/8 • 3 months
|
30.0%
3/10 • 3 months
|
22.2%
2/9 • 3 months
|
9.1%
1/11 • 3 months
|
20.0%
2/10 • 3 months
|
|
General disorders
Injection site discomfort
|
12.5%
1/8 • 3 months
|
10.0%
1/10 • 3 months
|
33.3%
3/9 • 3 months
|
9.1%
1/11 • 3 months
|
0.00%
0/10 • 3 months
|
|
General disorders
Injection site hemorrhage
|
37.5%
3/8 • 3 months
|
10.0%
1/10 • 3 months
|
33.3%
3/9 • 3 months
|
27.3%
3/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • 3 months
|
20.0%
2/10 • 3 months
|
22.2%
2/9 • 3 months
|
54.5%
6/11 • 3 months
|
40.0%
4/10 • 3 months
|
|
General disorders
Injection site hypoesthesia
|
12.5%
1/8 • 3 months
|
40.0%
4/10 • 3 months
|
22.2%
2/9 • 3 months
|
18.2%
2/11 • 3 months
|
20.0%
2/10 • 3 months
|
|
General disorders
Injection site induration
|
0.00%
0/8 • 3 months
|
10.0%
1/10 • 3 months
|
0.00%
0/9 • 3 months
|
9.1%
1/11 • 3 months
|
0.00%
0/10 • 3 months
|
|
General disorders
Injection site oedema
|
50.0%
4/8 • 3 months
|
70.0%
7/10 • 3 months
|
55.6%
5/9 • 3 months
|
54.5%
6/11 • 3 months
|
80.0%
8/10 • 3 months
|
|
General disorders
Injection site pain
|
75.0%
6/8 • 3 months
|
70.0%
7/10 • 3 months
|
55.6%
5/9 • 3 months
|
63.6%
7/11 • 3 months
|
80.0%
8/10 • 3 months
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • 3 months
|
20.0%
2/10 • 3 months
|
0.00%
0/9 • 3 months
|
9.1%
1/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
General disorders
Oedema
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
20.0%
2/10 • 3 months
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
General disorders
Facial Paresis
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
18.2%
2/11 • 3 months
|
0.00%
0/10 • 3 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
27.3%
3/11 • 3 months
|
0.00%
0/10 • 3 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
10.0%
1/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • 3 months
|
20.0%
2/10 • 3 months
|
0.00%
0/9 • 3 months
|
0.00%
0/11 • 3 months
|
20.0%
2/10 • 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • 3 months
|
0.00%
0/10 • 3 months
|
11.1%
1/9 • 3 months
|
0.00%
0/11 • 3 months
|
10.0%
1/10 • 3 months
|
Additional Information
Racheli Gueta, Director of Clinical Trials
Raziel Therapeutics
Phone: 972-8-9126941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place