Clinical trial NCT03982225: Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
Official title: A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate or Severe Submental Fullness
Keywords: Apoptosis
Lipolysis
Fat reduction
Submental fat
Polyene Phosphatidylcholine
Lead sponsor: AMIpharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-11
Enrollment: 143
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.

Detailed description: This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

Eligibility criteria: Inclusion Criteria:

1. Male and female over 19 and under 65 years old.
2. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
3. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
4. Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
5. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
2. Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
3. Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
4. Unable to undergo MRI by neurosis or general weakness.
5. History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
6. History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
7. Inflammation, scars or surgery on the injection area.
8. Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal.
9. Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
10. History of or present symptoms of dysphagia.
11. Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
12. Requiring treatment of joint inflammation or a lung disease.
13. Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c\> 9%).
14. Type 1 diabetes mellitus who needs insulin treatment.
15. Autoimmune disorder as well as those who takes immunodepressant drugs.
16. Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
17. Thyromegaly, thyrotoxicosis, or HIV-positive.
18. Diagnosed with malignant tumor within the last 5 years.
19. Severe renal dysfunction (serum creatinine \> 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase \> maximum rate of normality x 2.5).
20. History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
21. History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening.
22. History of other clinical trial studies within 3 months before screening.
23. Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
24. Judged to be unsuitable subject for the clinical trials.
25. No or unable to using Smart phone to fill in the e-Pro.
26. Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.

Primary outcomes:
measure: Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
timeFrame: Baseline and 12 weeks after last treatment
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline
timeFrame: Baseline and 12 weeks after last treatment
measure: Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area
timeFrame: Baseline and 12 weeks after last treatment
measure: Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner
timeFrame: Baseline and 12 weeks after last treatment
measure: Patient Global Impression of Change scale (PGIC)
timeFrame: 12 weeks after last treatment
measure: Change From Baseline in Derriford Appearance Scale 24 (DAS24)
timeFrame: Baseline and 12 weeks after last treatment
measure: Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
timeFrame: Baseline and 12 weeks after last treatment
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Dae Hyeon Lew, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: