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

NCT ID: NCT05266729

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-02-20

Brief Summary

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

Detailed 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.

Conditions

Moderate or Severe Submental Fullness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AYP-101 1

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.

Group Type: EXPERIMENTAL

Polyene Phosphatidylcholine

Intervention Type: DRUG

Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.

AYP-101 2

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.

Group Type: EXPERIMENTAL

Polyene Phosphatidylcholine

Intervention Type: DRUG

Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Phosphate buffered saline placebo for injection

Interventions

Polyene Phosphatidylcholine

Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.

Intervention Type: DRUG

Placebo

Phosphate buffered saline placebo for injection

Intervention Type: DRUG

Other Intervention Names

AYP-101

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AMIpharm Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AYP-101-202

Identifier Type: -

Identifier Source: org_study_id