Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat

AMIpharm

Status and phase: Completed; Phase 2

Conditions: Moderate or Severe Submental Fullness

Treatments: Drug: Placebo; Drug: Polyene phosphatidylcholine injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03982225

AYP-101-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 4 patient groups, including a placebo group

2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm

Experimental group

Description:

Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Polyene phosphatidylcholine injection

5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm

Experimental group

Description:

Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Polyene phosphatidylcholine injection

5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm

Experimental group

Description:

Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Polyene phosphatidylcholine injection

Placebo 0.2 mL/1.0 cm

Placebo Comparator group

Description:

Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Placebo