Submental Fat
Conditions
Brief summary
This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Detailed description
Screening Period: Subjects will be eligible to undergo screening after successful completion of (defined as completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the screening period, subjects will be assessed for study eligibility by evaluation of subjects' SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography. Day 0/Baseline: Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be recorded. Subjects will be asked about their pain levels using VAS. Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7, 28, 56 and 84 for efficacy and safety assessments. Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded.
Interventions
DRUGRZL-012
Ready to use drug product for injection into the subcutaneous fat
Sponsors
Raziel Therapeutics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Second injection session of RZL-012 will be administered to subjects who previously treated with RZL-012 in submental fat
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For a subject to be eligible for this study, he or she must meet all of the following criteria: 1. Is a male or female subject between the ages of 18 and 65 years, inclusive. 2. Previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 and whose current C-CAT score is 2, 3 or 4 3. Who successfully completed (as in completed the day 84 visit) the RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. 4. Has body mass index (BMI) between \>22 kg/m2 and \<40 kg/m2. 5. Has SMF bulge that is contiguous and can receive between 16 to 36 injections distanced 1 centimeter (cm) from each other according to the injection grid. 6. Has stable weight, with no fluctuation of \>5 kg in the past 12 months. 7. If female, is not pregnant or breastfeeding based on the following: 1. 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 2. is abstaining 3. is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or 4. is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause or 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. 8. 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. 9. Is willing to avoid strenuous exercise for seven (7) days post treatment. 10. Can adhere to the visit schedule and protocol requirements and be available to complete the study. 11. 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
* Subjects must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Adverse events follow up | 84 days | Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy -Change in score according to Clinician chin assessment tool (C-CAT) | 84 days | • Proportion of subjects who have at least a 1-grade improvement in C-CAT on Day 84 versus baseline in subjects receiving a second treatment session of RZL-012. Baseline is defined as the C-CAT assessment made immediately prior to the second treatment session |
Countries
United States
Outcome results
None listed