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.

NCT04086823 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-SMF-P2aUS-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse Events Follow up

  To evaluate the safety of RZL-012 subcutaneous injections in the submental area, relative to placebo, as assessed by spontaneous adverse event reports and post injection evaluation of subjects. Specifically, Pain, Induration, Bruising, Erythema and Edema will be closely followed up following treatment.

  0-84 days

Secondary Outcomes (3)

• Physician's Global Assessment

  0-84 days

• Efficacy: MRI Volume Reduction

  0-84 days

• Efficacy: Improvement in Face Satisfaction Questionnaire - A Score From 0 (Worst) to 100 (Best) Marks the Subject's Satisfaction

  0-84 days

Study Arms (2)

RZL-012

ACTIVE COMPARATOR

A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 48 sites in the submental fat (0.05/0.1mL per site): 1. Up to 120mg administered at 48 sites in a volume of 0.05 ml at each injection site (total injected volume 2.4mL) 2. Up to 240 mg administered at 48 sites in a volume of 1 ml at each injection site (total volume injected 4.8mL)

Drug: RZL-012

Vehicle

PLACEBO COMPARATOR

Subject receive a single-treatment injection. Multiple injections of the Placebo are administered at 48 sites (0.05/0.1mL per site) into the submental fat. Up to a total of 2.4 mL will be injected for placebo subjects enrolled during cohort 1. Up to a total of 4.8 mL will be injected for placebo subjects enrolled during cohort 2.

Drug: Placebo

Interventions

RZL-012 DRUG

Subcutaneous injection to the submental fat area

RZL-012

Placebo DRUG

Placebo

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

RZL-012

Results Point of Contact

• Title: Racheli Gueta , Director of Clinical trials
• Organization: Raziel Therapeutics

racheli@raziel-therapy.com

97289124670

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: February 25, 2020
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)