Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area

AMIpharm

Status and phase: Completed; Phase 2

Conditions: Moderate or Severe Submental Fullness

Treatments: Drug: Polyene Phosphatidylcholine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05266729

AYP-101-202

Details and patient eligibility

About

To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).

Full description

This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of AYP-101 S.C injection for the reduction of SMF who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

Enrollment: 96 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female over 19 and under 65 years old

• Localized submental fat under chin area and who meet all the following criteria.

  ① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1

  ② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1

• Stable weight over the last 6 months (body weight change within +/-10%), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period

• Singed informed consent

Exclusion criteria

• Allergic to beans, components of the clinical drug, or medical devices which used in this clinical trial (lidocaine, acetaminophen, sterile oil pan, alcohol swab, grid pad, needle, etc.)
• Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more)
• History of any treatment (orthognathic surgery, suction lipectomy, PPC or DCA injection) in the neck or chin area
• History of any treatment such as mesotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling with in 1 year, and a botox surgery within 6 months before screening
• 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 ④ Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy, Inflammation, scars, or surgery on the injection area
• History of or present symptoms of dysphagia
• Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening
• Requiring treatment of joint inflammation or a lung disease
• Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%)
• Type 1 diabetes mellitus who needs insulin treatment
• Autoimmune disorder as well as those who takes immunodepressant drugs
• Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel
• Thyromegaly, thyrotoxicosis, or HIV-positive
• Diagnosed with malignant tumor within the last 5 years
• Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, AST, alkaline phosphatase > maximum rate of normality x 2.5)
• History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.)
• 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
• History of other clinical trial studies within 6 months before screening
• Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, IUCD, spermicide, condoms etc.)
• Judged to be unsuitable subject for the clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

AYP-101 1

Experimental group

Description:

0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.

Treatment:

Drug: Polyene Phosphatidylcholine

AYP-101 2

Experimental group

Description:

0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.

Treatment:

Drug: Polyene Phosphatidylcholine

Placebo

Placebo Comparator group

Description:

0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.

Treatment:

Drug: Placebo