Efficacy and Safety of RZL-012 on Submental Fat Reduction

Completed · Phase 2 · Has a placebo group

Conditions studied: Submental Fat

In brief

A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days.

Key facts

Study ID

NCT04867434

Run by

Raziel Therapeutics Ltd.

People needed

151

Starts

2021-06-15

Expected to finish

2022-05-31

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is a male or female subject between the ages of 18 and 65 years, inclusive.
• Has body mass index (BMI) between >22 and <40.
• Has SMF area that is contiguous and fits to 32±4 injections sites according to a grid with 1 cm distance between injection points.
• Has moderate to severe grade 3 to 4 of SMF as rated by the C-SFS.
• Has moderate to severe grade 3 to 4 of SMF as rated by the P-SFS.
• 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 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.

You may not qualify if…

• 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.
• Has a pre-existing skin condition in the submental region that, at the Investigator's discretion, may confound evaluation or analysis.
• Has previously had treatments or surgery in the submentum, such as but not limited to, focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate, or neck lift.
• Has pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia, or facial nerve palsy.
• Has Dercum's Disease
• Has any pre-existing medical condition other than increased SMF that, at the Investigator's discretion, may result in increased submental fullness, such as but not limited to, thyroid enlargement, goiter, cervical lymphadenopathy, etc.
• Has a planned fat reduction procedure of any variety to the submental region for the duration of the study.
• Has medication or a history of coagulopathy.
• Has a history or family history of venous thrombotic disease.
• Has been treated chronically at least three (3) months prior to study entry with systemic steroids or immunosuppressive drugs.

Where it is running

• DenovaResearch — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.