Efficacy and Safety of RZL-012 on Submental Fat Reduction

NCT04867434 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-SMF-P2b-US-001
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (1)

• Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84

  To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Clinician Chin Assessment Tool (C-CAT). The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck

  84 days

Secondary Outcomes (3)

• Efficacy - the Proportion of Subjects With at Least 1-grade Improvement in Subject Chin Assessment Tool (S-CAT)

  84 days

• Efficacy - Relative Change in Submental Fat Volume on Day 84 vs. Baseline

  84 days

• Safety - Adverse Events Follow up

  84 days

Study Arms (3)

RZL-012 50mg/ml

ACTIVE COMPARATOR

Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses 270 mg for the high doses. Each injection point will be dosed with 7.5 mg for the high dose in a volume of 0.15 mL/injection site.

Drug: RZL-012

RZL-012 34mg/ml

ACTIVE COMPARATOR

Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses of 183.6 mg for the low dose. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose in a volume of 0.15 mL/injection site.

Drug: RZL-012

Placebo

PLACEBO COMPARATOR

Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL.

Drug: Placebo

Interventions

RZL-012 DRUG

small synthetic molecule for submental fat reduction

RZL-012 34mg/ml; RZL-012 50mg/ml

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

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:

• 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.

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead

Study Sites (1)

DenovaResearch

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

RZL-012

Results Point of Contact

• Title: Dr. Racheli Gueta, Director of Clinical Trials
• Organization: Raziel Therapeutics

racheli@raziel-therapy.com

97289124670

Study Officials

• Raceli Gueta, PhD

  Raziel Therapeutics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 30, 2021
• Study Start: June 15, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 31, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)