A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.

Completed · Phase 2 · Has a placebo group

Conditions studied: Submental Fat

In brief

Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012. The total of 28 subjects will be enrolled in 2 clinical sites.

Key facts

Study ID

NCT04086823

Run by

Raziel Therapeutics Ltd.

People needed

28

Starts

2020-02-25

Expected to finish

2020-09-16

Last updated by the study team

2023-11-18

Who can join

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

You may qualify if…

• Men and women 18-65 years old.
• Subjects with Body Mass Index <35
• Subjects must have submental skin fold thickness greater than 1.5 cm as measured with calipers.
• Males must be willing to be clean shaved for all study visits.
• Patient weight must be stable (no fluctuation of >15 pounds in the past year)
• Males or females in the age of fertility agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
• Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects must sign an IRB approved informed consent indicating they are aware of the investigational nature of the study.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from study participation:
• Unable to tolerate subcutaneous injection.
• Pregnant or lactating women.
• Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
• Any uncontrolled systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
• Treatment with botulinum toxin injections in the neck or chin area within 6 months before screening.
• Excessive submental skin laxity.
• Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• An active dermatitis or open wound in the proposed treatment area
• An active bacterial, fungal, or viral infection in the proposed treatment area
• Pre-existing skin condition in the submental region that may confound evaluation or analysis, at investigator discretion
• Previously treated with focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate to the submental region within the previous 6 months
• Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
• Pre-existing medical condition other than increased submental fat that may result in increased submental fullness such as but not limited to thyroid enlargement, goiter, cervical lymphadenopathy etc., at investigator discretion
• Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
• Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight.
• Subjects with medication or history of coagulopathy.
• Allergic subjects to Bendaryl.
• Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
• Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
• Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
• Claustrophobia or MRI incompatible device or implant.

Where it is running

• DeNova Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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