An Open Label Phase 2 Study to Evaluate the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events
Overview
- Phase
- Phase 1
- Intervention
- RZL-012+Celecoxib+Zyrtec
- Conditions
- Submental Fat
- Sponsor
- Raziel Therapeutics Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Safety - Adverse Events Follow up
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
Detailed Description
In the first stage of the study, 5 subjects will be randomized into each of the treatment groups. Study outcomes will be assessed up to one week thereafter to determine the need to modify additional study treatments. Subsequently up to 10 additional subjects will be randomized into each of the treatment groups for the second stage of the study. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a single treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days. Each subject will be treated with the same dose of RZL-012 : • RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012, Each subject will receive additional study treatments in accordance with the treatment group to which the subject is randomized.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is a male or female subject between the ages of 18 and 65 years, inclusive.
- •Has body mass index (BMI) between \>22 kg/m2 and \<40 kg/m
- •Has SMF bulge that is contiguous and fits to 32±4 injections sites according to a grid with 1 centimeter (cm) distance between injection points.
- •Has grade 3 to 4 of SMF as rated by both the C-CAT and S-CAT.
- •Has stable weight, with no fluctuation of \>5 kg in the past 12 months.
- •If female, is not pregnant or breastfeeding based on the following:
- •agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 4 weeks after the last day of study drug and a negative serum pregnancy test (ß-hCG) at screening and negative urine pregnancy test at baseline; or
- •is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or
- •is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause and documented serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL or another documented medical condition (e.g., was born without a uterus)) NOTE: The following are considered highly effective contraceptive methods: hormonal oral contraceptives, injectables, and patches; intrauterine devices; double-barrier methods (synthetic condom, diaphragm, or cervical cap used with spermicidal foam, cream, or gel); and male partner sterilization.
- •If male (with or without vasectomy), agree to the use of highly effective contraceptive methods as listed above in criteria 7 as well as to use a barrier method, e.g. condom , from study check-in until 7 days after drug injection.
Exclusion Criteria
- •Is unable to tolerate subcutaneous injections.
- •Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- •Has any systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease.
- •Has any contraindications to oral corticosteroids (prednisone), NSAIDs (e.g., Celecoxib) or non-sedative antihistamines (e.g. Zyrtec)
- •Has skin laxity (i.e., elastosis, skin crepiness, skin redundancy, skin draping, vertical and/or horizontal skin bands and folds, blunting of cervical mental angle, loss of opposition of skin to underlying neck structures due to skin laxity) that could obscure the evaluation and treatment of SMF.
- •Has any scars, unshaven hair, tattoos, facial hair or jewelry on or near the proposed treatment area.
- •Has presence of structures or confounding factors that may interfere with assessing SMF such as but not limited to enlarged submandibular salivary and/or parotid glands, micrognanthia, chin implant, soft tissue volume augmentation of chin and/or jawline, pronounced platysmal bands and deep necklace lines or presence of facial jowls that could obscure the evaluation of SMF.
- •Has a fat bulge under the chin that is too large to be adequately treated by 32±4 contiguous injections on a 1cm grid .
- •Has a fat bulge under the chin that is of an insufficient volume to allow 32±4 injections within a contiguous 1 cm grid.
- •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.
Arms & Interventions
RZL-012 50mg/ml
Intervention: RZL-012+Celecoxib+Zyrtec
RZL-012 50mg/ml
Intervention: RZL-012+facial and neck wrap
RZL-012 50mg/ml
Intervention: RZL-012
RZL-012 50mg/ml
Intervention: RZL-012+Lidacaine injection prior treatment
RZL-012 50mg/ml
Intervention: RZL-012+Medrol
Outcomes
Primary Outcomes
Safety - Adverse Events Follow up
Time Frame: 84 days
Number of subjects with severe swelling in each subgroup
Secondary Outcomes
- Efficacy -Reduction in Score According to Clinician Chin Assessment Tool (C-CAT)(84 days)
- Efficacy - Percentage of Change From Baseline in Submental Fat Volume(84 days)
- Efficacy - Number of Participants With 1 Grade Improvement According to the Subject Chin Assessment Tool (S-CAT)(84 days)