Efficacy and Safety of RZL-012 on Submental Fat Reduction

Inclusion Criteria

• Is a male or female subject between the ages of 18 and 65 years, inclusive.
• Has body mass index (BMI) between >22 and 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 7 days 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 in Criterion #7 above) from study check-in until 7 days after the last day of study drug.
• Is willing to avoid strenuous exercise for seven (7) days post treatment.
• Is able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• 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

Subjects must NOT meet any of the following Exclusion criteria to be eligible for enrollment:

• Is unable to tolerate subcutaneous injections.
• Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
• Has any uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
• Has had treatment with botulinum toxin injections in the neck or chin area within nine (9) months prior to screening.
• 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.
• 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 an extreme fat bulge under the chin and the submental fat was previously rated as 'very severe'.
• Has fat extends down the neck beyond the Adam's Apple, towards the base of the neck where the fat extends laterally along the jawline making the jawline indistinguishable from the neck.
• 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 significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
• Has an active dermatitis or open wound in the proposed treatment area.
• Has abnormal coagulation tests (PT, PTT)
• Has D-dimer value >0.64mg/L in screening visit
• Has an active bacterial, fungal, or viral infection in the proposed treatment area.

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