Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events

NCT05476679 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RZL-012-SMF-SWMTG-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (1)

• Safety - Adverse Events Follow up

  Number of subjects with severe swelling in each subgroup

  84 days

Secondary Outcomes (3)

• Efficacy -Reduction in Score According to Clinician Chin Assessment Tool (C-CAT)

  84 days

• Efficacy - Number of Participants With 1 Grade Improvement According to the Subject Chin Assessment Tool (S-CAT)

  84 days

• Efficacy - Percentage of Change From Baseline in Submental Fat Volume

  84 days

Study Arms (1)

RZL-012 50mg/ml

EXPERIMENTAL

Drug: RZL-012; Drug: RZL-012+Lidacaine injection prior treatment; Drug: RZL-012+Medrol; Drug: RZL-012+Celecoxib+Zyrtec; Drug: RZL-012+facial and neck wrap

Interventions

RZL-012 DRUG

50mg/ml drug formulation

RZL-012 50mg/ml

RZL-012+Lidacaine injection prior treatment DRUG

5ml lidocaine will be injected 10 minutes before RZL-012 treatment

RZL-012 50mg/ml

RZL-012+Medrol DRUG

oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use

RZL-012 50mg/ml

RZL-012+Celecoxib+Zyrtec DRUG

200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6

RZL-012 50mg/ml

RZL-012+facial and neck wrap DRUG

Universal Facial Band

RZL-012 50mg/ml

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 kg/m2 and \<40 kg/m2.
• Has SMF bulge that is contiguous and fits to 32±4 injections sites according to a grid with 1 centimeter (cm) distance between injection points.
• Has grade 3 to 4 of SMF as rated by both the C-CAT and S-CAT.
• 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 4 weeks 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 above in criteria 7 as well as to use a barrier method, e.g. condom , from study check-in until 7 days after drug injection.
• 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 systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease.
• Has any contraindications to oral corticosteroids (prednisone), NSAIDs (e.g., Celecoxib) or non-sedative antihistamines (e.g. Zyrtec)
• 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 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 a fat bulge under the chin that is too large to be adequately treated by 32±4 contiguous injections on a 1cm grid .
• Has a fat bulge under the chin that is of an insufficient volume to allow 32±4 injections within a contiguous 1 cm grid.
• 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 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.

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead

Study Sites (1)

Luxurgery

Manhattan, New York, 10021, 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

972-8-9126941

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: September 25, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)