Phase 2
N=12
Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
Flank Mass
Bottom Line
View on ClinicalTrials.gov: NCT05445557 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events [AEs] — 12; 12; 9; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RZL-012 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Raziel Therapeutics Ltd.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events [AEs] |
12; 12; 9; 12; 12; 9 | — |
| SECONDARY Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale |
7; 0; 0; 2; 0; 0 | — |
| SECONDARY Efficacy - Change in Satisfaction Score |
9; 2; 1; 10; 6; 3 | — |
| SECONDARY Efficacy - Relative Change in Measured Fat Volume |
-37; 33; -48.9 | — |
| SECONDARY Efficacy -Number of Participant With Correct Identification by Reviewers |
5; 6 | — |
| SECONDARY Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) |
961.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) BMI of ≥ 22 and 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.
Exclusion Criteria
- 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).
- Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study
Data sourced from ClinicalTrials.gov (NCT05445557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.