Trial Outcomes & Findings for Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks (NCT NCT05445557)
NCT ID: NCT05445557
Last Updated: 2023-11-18
Results Overview
Safety
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Results posted on
2023-11-18
Participant Flow
Unit of analysis: flanks
Participant milestones
| Measure |
All Study Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
RZL-012: small synthetic molecule for submental fat reduction
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|---|---|
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Double Blind Part
STARTED
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12 24
|
|
Double Blind Part
Flanks Treated With RZL-012
|
12 12
|
|
Double Blind Part
Flanks Treated With Placebo
|
12 12
|
|
Double Blind Part
COMPLETED
|
11 22
|
|
Double Blind Part
NOT COMPLETED
|
1 2
|
|
Open Label - Active Only
STARTED
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9 9
|
|
Open Label - Active Only
COMPLETED
|
9 9
|
|
Open Label - Active Only
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
| Measure |
All Study Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
RZL-012: small synthetic molecule for submental fat reduction
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|---|---|
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Double Blind Part
Lost to Follow-up
|
1
|
Baseline Characteristics
The results from the double blind phase and open label phase are presented. The number of subjects that continued to the open label phase were 9.
Baseline characteristics by cohort
| Measure |
RZL-012 50mg/ml or Placebo
n=12 Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
RZL-012: small synthetic molecule for submental fat reduction
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
|
|---|---|
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Age, Continuous
Double blind phase
|
43 years
STANDARD_DEVIATION 12.2 • n=12 Participants • The results from the double blind phase and open label phase are presented. The number of subjects that continued to the open label phase were 9.
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|
Age, Continuous
Open Label phase
|
44.1 years
STANDARD_DEVIATION 10.6 • n=9 Participants • The results from the double blind phase and open label phase are presented. The number of subjects that continued to the open label phase were 9.
|
|
Sex: Female, Male
Double blind phase · Female
|
10 Participants
n=12 Participants • The results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Sex: Female, Male
Double blind phase · Male
|
2 Participants
n=12 Participants • The results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Sex: Female, Male
Open Label phase · Female
|
7 Participants
n=9 Participants • The results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Sex: Female, Male
Open Label phase · Male
|
2 Participants
n=9 Participants • The results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · American Indian or Alaska Native
|
0 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · Asian
|
0 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · Black or African American
|
2 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · White
|
10 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · More than one race
|
0 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Double Blind phase · Unknown or Not Reported
|
0 Participants
n=12 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · American Indian or Alaska Native
|
0 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · Asian
|
0 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · Black or African American
|
1 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · White
|
8 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · More than one race
|
0 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
|
Race (NIH/OMB)
Open label phase · Unknown or Not Reported
|
0 Participants
n=9 Participants • he results from the double blind phase are presented together with the results from the open label phase. Only 9 subjects continued to the open label phase
|
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Region of Enrollment
United States
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12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label PhasePopulation: The data for double blind and open label phase are presented. A total of 9 subjects continued to open label phase.
Safety
Outcome measures
| Measure |
RZL-012 50mg/ml
n=12 Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
n=12 Participants
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
n=9 Participants
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events [AEs]
AE Related Study Treatment
|
12 participants
|
12 participants
|
9 participants
|
|
Number of Participants With Treatment-related Adverse Events [AEs]
Related to Injection Procedure
|
12 participants
|
12 participants
|
9 participants
|
|
Number of Participants With Treatment-related Adverse Events [AEs]
Severe Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label PhasePopulation: A total of 9 subjects continued to the open label phase
To compare the proportion of flanks having an improvement as indicated by reduction in score from 6 to 0 according to the Physician Global Assessment Scale (GAIS) in RZL-01-treated flanks vs placebo-treated flanks
Outcome measures
| Measure |
RZL-012 50mg/ml
n=11 Flanks
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
n=11 Flanks
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
n=9 Flanks
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
Marked Improvement
|
7 flanks
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0 flanks
|
0 flanks
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|
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
Moderate Improvement
|
2 flanks
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0 flanks
|
0 flanks
|
|
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
Slight Improvement
|
1 flanks
|
0 flanks
|
7 flanks
|
|
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
No Change
|
1 flanks
|
11 flanks
|
2 flanks
|
SECONDARY outcome
Timeframe: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label PhasePopulation: A total of 9subjects continued to the open label phase
To compare the proportion of subjects who are satisfied with treatment results as indicated by a binary yes/no satisfaction questionnaire in RZL-012-treated flanks vs placebo-treated flanks
Outcome measures
| Measure |
RZL-012 50mg/ml
n=11 Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Efficacy - Change in Satisfaction Score
RZL-012 - Double blind phase · Satisfied
|
9 Participants
|
—
|
—
|
|
Efficacy - Change in Satisfaction Score
RZL-012 - Double blind phase · Not Satisfied
|
2 Participants
|
—
|
—
|
|
Efficacy - Change in Satisfaction Score
Placebo Double blind phase · Satisfied
|
1 Participants
|
—
|
—
|
|
Efficacy - Change in Satisfaction Score
Placebo Double blind phase · Not Satisfied
|
10 Participants
|
—
|
—
|
|
Efficacy - Change in Satisfaction Score
RZL-012 Open Label phase · Satisfied
|
6 Participants
|
—
|
—
|
|
Efficacy - Change in Satisfaction Score
RZL-012 Open Label phase · Not Satisfied
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatmentPopulation: A total of 9 subjects continued to the open label phase
Measure the relative mean reduction in volume (%) at post treatment vs. baseline for each of the treated flanks, as measured by 3D images using the Canfield 3D system in RZL-012-treated flanks vs placebo-treated flanks at 12 weeks vs. baseline
Outcome measures
| Measure |
RZL-012 50mg/ml
n=11 Flanks
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
n=11 Flanks
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
n=9 Flanks
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Efficacy - Relative Change in Measured Fat Volume
|
-37 percentage of change from baseline.
Standard Deviation 55.2
|
33 percentage of change from baseline.
Standard Deviation 41.4
|
-48.9 percentage of change from baseline.
Standard Deviation 65.9
|
SECONDARY outcome
Timeframe: 12 weeks 12 weeks for the Double-Blind PhaseBlinded reviewers will identify, per patient, the flank treated with test compound (active) vs the flank treated with Placebo. Success will be defined as at least 70% correct identification vs the expected 50% correct identification based on random guessing
Outcome measures
| Measure |
RZL-012 50mg/ml
n=11 Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Efficacy -Number of Participant With Correct Identification by Reviewers
Reviewer 1 - Correct identification of active treated flanks
|
5 Participants
|
—
|
—
|
|
Efficacy -Number of Participant With Correct Identification by Reviewers
Reviewer 2 - Correct identification of active treated flanks
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 hoursMeasurement of maximum drug concentration (Cmax) (ng/mL) in the blood
Outcome measures
| Measure |
RZL-012 50mg/ml
n=6 Participants
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
|
Placebo
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
RZL-012: small synthetic molecule for submental fat reduction
|
RZL-012 Open Label
Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012
|
|---|---|---|---|
|
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
|
961.8 ng/ml
Standard Error 273.4
|
—
|
—
|
Adverse Events
RZL-012 50mg/ml
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RZL-012 50mg/ml
n=12 participants at risk
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
RZL-012: small synthetic molecule for submental fat reduction
|
Placebo
n=12 participants at risk
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.
Placebo: Placebo
|
|---|---|---|
|
General disorders
edema
|
91.7%
11/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
100.0%
12/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
General disorders
pain
|
100.0%
12/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
100.0%
12/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
General disorders
tenderness
|
33.3%
4/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
8.3%
1/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Nervous system disorders
Hypoesthesia
|
41.7%
5/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
8.3%
1/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
50.0%
6/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
66.7%
8/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
erythema
|
58.3%
7/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
50.0%
6/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
91.7%
11/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
58.3%
7/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
General disorders
edema Open Label phase
|
100.0%
9/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
General disorders
pain open label phase
|
100.0%
9/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
General disorders
Tenderness - Open Label phase
|
22.2%
2/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Nervous system disorders
Hypoesthesia Open Label phase
|
77.8%
7/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Erythema open label phase
|
77.8%
7/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Pruritus Open Label phase
|
22.2%
2/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation open label phase
|
33.3%
3/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
|
Skin and subcutaneous tissue disorders
Skin irritation Open Label phase
|
11.1%
1/9 • 12 weeks Double blind phase and 12 weeks open label phase
|
0.00%
0/12 • 12 weeks Double blind phase and 12 weeks open label phase
|
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