Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: RZL-012
small synthetic molecule for submental fat reduction
|
| Placebo Comparator: 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. |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- The incidence of Treatment-related Adverse Events [AEs] [12 weeks]
Safety
Secondary Outcome Measures
- Efficacy - Change in score according Physician Global Assessment Scale [12 weeks]
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
- Efficacy - Change in satisfaction score [12 weeks]
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
- Efficacy - fat volume change [12 weeks]
Measure the mean reduction in volume (mm^3)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
- Efficacy -Change in fat volume [12 weeks]
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
- Pharmacokinetics measure - drug concentration in the blood (ng/mL) [30 hours]
Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is a male or female subject between the ages of 18 and 65 years, inclusive.
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Has body mass index (BMI) BMI of ≥ 22 and < 30.
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Has clearly visible and palpable fat in the flanks
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Has symmetrical appearance of right and left flanks
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Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
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Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.
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If female, is not pregnant or breastfeeding based on the following:
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agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 28 days after the last day of study drug and a negative urine pregnancy test at screening and baseline; or
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is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or
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is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause, having documented serum follicle-stimulating hormone (FSH) level > 40 mIU/mL, or having another documented medical condition (e.g., was born without a uterus))
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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.
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Is willing to avoid strenuous exercise for seven (7) days post treatment.
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Is motivated to adhere to the visit schedule and protocol requirements.
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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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Is unable to tolerate subcutaneous injections.
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Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
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Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
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Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.
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Has medication or a history of coagulopathy.
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Has a history or family history of venous thrombotic disease.
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Had a non-invasive fat reduction and/or body contouring procedure in the flanks within the past 12 months.
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Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.
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Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
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Has an active dermatitis or open wound in the proposed treatment area.
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Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) > ULN, international normalized ratio (INR) > ULN reference range (> 1.3), prothrombin time (PT) > ULN.
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Has an active bacterial, fungal, or viral infection in the proposed treatment area.
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Has known allergic reactions to any injectables.
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Has been treated chronically in the past 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
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Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs).
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Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Luxurgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Raziel Therapeutics Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RZL-012-FL-P2US-001