Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks

NCT05445557 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-FL-P2US-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After codes opening, a second treatment cycle on the previously untreated contralateral flank will be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.

Conditions

Flank Mass

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events [AEs]

  Safety

  12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase

Secondary Outcomes (5)

• Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale

  12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase

• Efficacy - Change in Satisfaction Score

  12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase

• Efficacy - Relative Change in Measured Fat Volume

  12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatment

• Efficacy -Number of Participant With Correct Identification by Reviewers

  12 weeks 12 weeks for the Double-Blind Phase

• Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)

  30 hours

Study Arms (2)

RZL-012 50mg/ml

ACTIVE COMPARATOR

Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.

Drug: RZL-012

Placebo

PLACEBO COMPARATOR

Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.

Drug: Placebo

Interventions

RZL-012 DRUG

small synthetic molecule for submental fat reduction

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) BMI of ≥ 22 and \< 30.
• Has clearly visible and palpable fat in the flanks
• Has symmetrical appearance of right and left flanks
• Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
• Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.
• 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 28 days after the last day of study drug and a negative urine pregnancy test at screening and 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, having documented serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL, or having another documented medical condition (e.g., was born without a uterus))
• If male (with or without vasectomy), agree to the use of highly effective contraceptive methods, e.g. condom, from study baseline until 7 days after the last day of study drug.
• Is willing to avoid strenuous exercise for seven (7) days post treatment.
• Is motivated to adhere to the visit schedule and protocol requirements.
• 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 an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
• 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 medication or a history of coagulopathy.
• Has a history or family history of venous thrombotic disease.
• Had a non-invasive fat reduction and/or body contouring procedure in the flanks within the past 12 months.
• Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.
• 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.
• Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) \> ULN, international normalized ratio (INR) \> ULN reference range (\> 1.3), prothrombin time (PT) \> ULN.
• Has an active bacterial, fungal, or viral infection in the proposed treatment area.
• Has known allergic reactions to any injectables.
• Has been treated chronically in the past 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
• Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs).

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead

Study Sites (1)

Luxurgery

New York, 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

97289124670

Publication Agreements

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

Study Design

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

Model Details: Each of the subject's flanks will be randomized for RZL-012 and placebo injections.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: July 6, 2022
• Study Start: March 10, 2022
• Primary Completion: October 20, 2022
• Study Completion: November 10, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)