Healthy
Conditions
Brief summary
To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults
Detailed description
This study is to evaluate efficacy and safety of AYP-101 S.C injection for the reduction of Submental Fat who wish improvement in the appearance of moderate to severe convexity or fullness associated with Submental Fat in adults
Interventions
Formulated as an injectable solution containing Polyene Phosphatidylcholine at concentration of 25 mg/mL
DRUGMatching placebo of AYP-101
Phosphate buffered saline placebo for injection
Sponsors
AMIpharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Masking
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females aged 19 to 65 (inclusive) 2. Patient with submental subcutaneous fat deposited who meet all of the following: * Patient with ER-SMFRS and SR-SMFRS Grade 2 (moderate) or 3 (severe) at visit 1 * Subject Self Satisfaction Scale (SSSS) Grade 2 (slightly dissatisfied) or less at visit 1 3. Patient who has stably maintained body weight for the past 6 months (weight change within ±10% of subject's weight); agrees to refrain from exercise and diet that may affect the study result during the study period and maintain pre-study exercise/diet during the study period 4. Able to comply with the protocol visit schedule and plans 5. Voluntarily provides written informed consent
Exclusion criteria
1. Allergic to IP component (soy) and lidocaine or medical devices used in this clinical trial (sterile permanent marker, alcohol swab, administration site design grid pad, injection needle, etc.) 2. Has morbid obesity of central, endocrine, and genetic nature (BMI ≥ 35 kg/m2 at screening) 3. History of plastic surgery (liposuction) or injection containing phosphatidylcholine or deoxycholic acid at the planned IP administration site for the purpose of submental fat reduction or history of double jaw surgery 4. History of following procedures at the planned IP administration site * Thread lifting, implants, dermal fillers with active ingredient other than hyaluronic acid or collagen, or semi-permanent fillers within 12 months prior to visit 2 * Dermal fillers with active ingredient hyaluronic acid or collagen or Botulinum toxin procedure within 6 months prior to visit 2 (including entire chin and neck area) * Focused ultrasound, radiofrequency or cryolipolysis within 6 months prior to visit 2 * Laser therapy, optic therapy, or chemical dermabrasion procedure within 3 months prior to visit 2 5. Deemed inappropriate for the study by the investigator, such as the following: * Skin at the administration site is sagging or deformed * Has a prominent platysmal band under the chin * Has a short chin; jawbone in the lower jaw developed less than normal * Has a condition (e.g., cervical lymphadenopathy), inflammation, wound or surgical scar in the chin or the neck that is deemed to affect study assessments * Has any other factors deemed to affect evaluations by the investigator (evaluator) 6. History of dysphagia or current symptoms of dysphasia 7. Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening 8. Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.) 9. Uncontrolled hypertension (sitSBP ≥180 mmHg or sitDBP ≥110 mmHg at screening) 10. Uncontrolled type 2 diabetes (HbA1c \> 9% at screening) or type 1 diabetes 11. Has an autoimmune disease or receiving immunosuppressants 12. Receiving anticoagulants such as warfarin and clopidogrel or has a coagulation disorder 13. Has thyromegaly or hyperthyroidism 14. HIV-positive 15. Diagnosis of malignancy within the last 5 years 16. Severe renal dysfunction (serum creatinine \> 2.0 mg/dl at screening) 17. Severe liver dysfunction (ALT, AST or ALP \> upper limit of normal x 2.5 at screening) 18. A history of or currently suffering from a serious psychiatric condition (e.g., depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia) 19. Administration of drugs that may affect the body weight and lipid metabolism, such as appetite suppressants, oral steroids, thyroid hormones, amphetamines, cyproheptadine, phenothiazines or drugs that may affect absorption, metabolism and excretion within 3 months of screening 20. Receipt of any other IPs within 3 months prior to IP administration 21. Pregnant or lactating women, or subjects who are planning to become pregnant 22. Failure to agree to use a contraceptive method that is highly effective when used correctly, alone or in combination, continuously throughout the study and up to 3 months after the final IP administration 23. Deemed ineligible to be a study subject by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-primary Outcome Measure 1 | at 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 1 grade improvement in both ER-SMFRS(Evaluator Reported Submental Fat Rating Scale) and SR-SMFRS(Subject Reported Submental Fat Rating Scale) |
| Co-primary Outcome Measure 2 | at 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At least 1 grade improvement in both ER-SMFRS and SR-SMFRS | at 4 weeks after the final administration compared to baseline | Ratio of subjects with at least 1 grade improvement in both ER-SMFRS and SR-SMFRS |
| At least 2 grade improvement in both ER-SMFRS and SR-SMFRS | at 4 weeks after the final administration compared to baseline | Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS |
| At least 1 grade improvement in ER-SMFRS | at 4 and 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 1 grade improvement in ER-SMFRS |
| At least 2 grades improvement in ER-SMFRS | at 4 and 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 2 grades improvement in ER-SMFRS |
| At least 1 grade improvement in SR-SMFRS | at 4 and 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 1 grade improvement in SR-SMFRS |
| At least 2 grades improvement in SR-SMFRS | at 4 and 12 weeks after the final administration compared to baseline | Ratio of subjects with at least 2 grades improvement in SR-SMFRS |
| SSSS(Subject Self Satisfaction Scale) | at 4 and 12 weeks after the final administration | Ratio of subjects with SSSS of at least 4 points |
| PR-SMFIS(Patient Reported Submental Fat Impact Scale) | at 4 and 12 weeks after the final administration | Change in average PR-SMFIS score from baseline, In detail, it is a tool on which subjects measure how their submental fat looks on a scale of 0 to 10 points b y responding to 6 questions. Item 1 is in regard to satisfaction, and items 2 to 6 are questions in regard to dissatisfaction; all items will be calculated on a dissatisfaction scale\* and mean will be calculated. * Item 1 dissatisfaction scale = 10 (points) - Item 1 score * Items 2 to 6 dissatisfaction scale = each item score Each item in the PR-SMFIS is scored from 0 to 10, with a higher total score indicating greater dissatisfaction. |
| PGIC(Patient Global Impression of Change) | at 4 and 12 weeks after the final administration | PGIC evaluation |
| 3D imaging | at 4 and 12 weeks after the final administration | Change in subject's submental fat volume by 3D imaging from baseline |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORBeomjoon Kim, MD
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Outcome results
None listed