Phase 2
N=15
An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.
Submental Fat
Bottom Line
View on ClinicalTrials.gov: NCT05466448 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) — 487.7; 473.3 concentration (ng/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RZL-012 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Raziel Therapeutics Ltd.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) |
487.7; 473.3 | — |
| PRIMARY Pharmacokinetics Measure - Area Under the Plasma Concentration Versus Time Curve (AUC) (mg*h/L) |
4574.4; 4718.0 | — |
| SECONDARY Efficacy -Change in Score According to Clinician Chin Assessment Tool (C-CAT) |
4; 7 | — |
| SECONDARY Efficacy - Change in Score According to Subject Chin Assessment Tool (S-CAT) |
4; 7 | — |
| SECONDARY Efficacy - Change in Submental Fat Thickness |
-34.3; -24.6 | — |
| SECONDARY Safety - Adverse Events Follow up |
6; 9 | — |
Summary
This is a Phase 2, open label study that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period. The single treatment session will consist of multiple injections of RZL-012 into the submental area under the chin. Blood samples will be collected from all subjects for PK analyses in the first 30 hours after dosing. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Eligibility Criteria
Inclusion Criteria
- 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 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))
- 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 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.
Exclusion Criteria
- 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 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.
- Has allergic reactions to injectables.
- Has any pre-existing medical condition other than increased SMF that, at the Investigator's discretion, may result in increased submental fullness, such as but not limited to, thyroid enlargement, goiter, cervical lymphadenopathy, etc.
- Has a planned fat reduction procedure of any variety to the submental region for the duration of the study.
- Has medication or
Data sourced from ClinicalTrials.gov (NCT05466448). 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.