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A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After codes opening, a second treatment cycle on the previously untreated contralateral flank will be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.
This clinical trial is comprised of a double-blind, placebo-controlled phase followed by an open-label phase.
The double-blind, placebo-controlled phase of the trial will consist of a screening period, baseline visit and a 12-week post-treatment follow-up period. At the baseline visit, each flank (right and left) of each study participant will be randomized into either the active RZL-012 treatment group or the placebo group and each flank will receive multiple injections in a single session of RZL-012 or placebo. Blood samples will be collected for 6 of the 12 subjects for PK analyses. All subjects will be followed up for 12 weeks after the single treatment session.
Upon completion of the double-blind phase of the study, and the opening of codes subjects will be offered RZL-012 open-label treatment in the flank previously treated with placebo. Consenting subjects will be followed for safety and efficacy for an additional 12 weeks.
In both the double-blind and open-label phases of the study, subjects will be monitored for adverse events (AEs). Subjects will return to the site for visits at 1 week, 4 weeks, 8 weeks, and 12 weeks post treatment and will be monitored for safety and efficacy during these visits.
Subjects who will be collected with PK will return to the clinic at Day 1 post injection for further PK samples.
The dimensions of flanks will be measured using 3D images and volumetric calculations using Canfield 3D images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RZL-012 50mg/ml | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RZL-012 | Drug | small synthetic molecule for submental fat reduction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events [AEs] | Safety | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale | 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 | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase |
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Inclusion Criteria:
Is a male or female subject between the ages of 18 and 65 years, inclusive.
Has body mass index (BMI) BMI of ≥ 22 and < 30.
Has clearly visible and palpable fat in the flanks
Has symmetrical appearance of right and left flanks
Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.
If female, is not pregnant or breastfeeding based on the following:
If male (with or without vasectomy), agree to the use of highly effective contraceptive methods, e.g. condom, from study baseline until 7 days after the last day of study drug.
Is willing to avoid strenuous exercise for seven (7) days post treatment.
Is motivated to adhere to the visit schedule and protocol requirements.
Is willing and able to sign an Institutional Review Board (IRB) approved informed consent form (ICF) indicating that they are aware of the investigational nature of the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luxurgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind Part |
|
| ||||||||||||||||||||||||
| Open Label - Active Only |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RZL-012 50mg/ml or Placebo | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events [AEs] | Safety | The data for double blind and open label phase are presented. A total of 9 subjects continued to open label phase. | Posted | Number | participants | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase |
|
12 weeks Double blind phase and 12 weeks open label phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RZL-012 50mg/ml | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| edema | General disorders | Non-systematic Assessment | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Racheli Gueta, Director of Clinical Trials | Raziel Therapeutics | 97289124670 | racheli@raziel-therapy.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2022 | Jul 24, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2022 | Jul 24, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| C000720429 | RZL-012 |
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Each of the subject's flanks will be randomized for RZL-012 and placebo injections.
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| Placebo |
| Drug |
Placebo |
|
| Efficacy - Change in Satisfaction Score | 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 | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase |
| Efficacy - Relative Change in Measured Fat Volume | 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 | 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 treatment |
| Efficacy -Number of Participant With Correct Identification by Reviewers | Blinded 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 | 12 weeks 12 weeks for the Double-Blind Phase |
| Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) | Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood | 30 hours |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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 | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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 | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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
| OG002 | RZL-012 Open Label | Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012 |
|
|
| Secondary | Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale | 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 | A total of 9 subjects continued to the open label phase | Posted | Number | flanks | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase | Flanks | Flanks |
|
|
|
| Secondary | Efficacy - Change in Satisfaction Score | 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 | A total of 9subjects continued to the open label phase | Posted | Count of Participants | Participants | 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase |
|
|
|
| Secondary | Efficacy - Relative Change in Measured Fat Volume | 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 | A total of 9 subjects continued to the open label phase | Posted | Mean | Standard Deviation | percentage of change from baseline. | 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 treatment | Flanks | Flanks |
|
|
|
| Secondary | Efficacy -Number of Participant With Correct Identification by Reviewers | Blinded 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 | Posted | Count of Participants | Participants | 12 weeks 12 weeks for the Double-Blind Phase |
|
|
|
| Secondary | Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) | Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood | Posted | Mean | Standard Error | ng/ml | 30 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 12 | 12 |
|
| pain | General disorders | Non-systematic Assessment | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS |
|
| tenderness | General disorders | Non-systematic Assessment | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS |
|
| Hypoesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| edema Open Label phase | General disorders | Non-systematic Assessment |
|
| pain open label phase | General disorders | Non-systematic Assessment |
|
| Tenderness - Open Label phase | General disorders | Non-systematic Assessment |
|
| Hypoesthesia Open Label phase | Nervous system disorders | Non-systematic Assessment |
|
| Erythema open label phase | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus Open Label phase | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Hyperpigmentation open label phase | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin irritation Open Label phase | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Slight Improvement |
|
| No Change |
|
| Placebo Double blind phase |
|
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| RZL-012 Open Label phase |
|
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