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

A Single Center, Randomized, Placebo Controlled Phase Ⅱ Study to Determine the Dosing Interval and the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat

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

Study Overview

• Status: Completed
• Conditions: Moderate or Severe Submental Fullness
• Intervention / Treatment: Drug: Placebo; Drug: Polyene Phosphatidylcholine

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06973
    • Chung Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Polyene Phosphatidylcholine; Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.; Other Names: AYP-101
Experimental: 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.	Drug: Polyene Phosphatidylcholine; Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.; Other Names: AYP-101
Placebo Comparator: 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.	Drug: Placebo; Phosphate buffered saline placebo for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who improved at least 1 grade in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (PR-SMFRS)	Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	4 weeks after the final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who improved at least 1 grade in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (SR-SMFRS)	Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	12 weeks after the final treatment
Percentage of subjects who improved at least 1 grade of Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)	Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	4 and 12 weeks after the final treatment
Percentage of subjects who improved at least 1 grade of Subject-Reported Submental Fat Rating Scale (SR-SMFRS)	Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	4 and 12 weeks after the final treatment
Volume difference of pre-platysmal submental fat around chin area	Volume of pre-platysmal submental fat around chin area was measured using MRI	4 weeks after the final treatment
Volume difference of platysmal submental fat around chin area	Volume of platysmal submental fat around chin area was measured using MRI	4 weeks after the final treatment
Percentage of subjects who improved at least 2 grades in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (SR-SMFRS)	Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	4 and 12 weeks after the final treatment
Difference of Subject Self Satisfaction Scale (SSSS)	Subject Self Satisfaction Scale (SSSS) assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 with 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.	4 and 12 weeks after the final treatment
Difference of Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score	Patients are asked to rate the visual and emotional impact that the appearance of submental fullness had on their self-perception using 11-point scale range from 0 (no impact) to 10 (extreme impact).	4 and 12 weeks after the final treatment
Difference of volume of submental fat around chin area analyzed with 3D	Volume of submental fat around chin area is measured using a 3D scanner photograph	4 weeks after the final treatment
Patient Global Impression of Change scale (PGIC)	Patient global impression of change scale (PGIC) is to rate patients total improvement or worsening in the appearance since before the first treatment compared to final treatment with 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.	4 weeks after the final treatment
Difference of Derriford Appearance Scale 24 (DAS24)	Difference of Derriford Appearance Scale 24 (DAS24) score is to measure distress and dysfunction to problems of appearance with 24 item scale.	4 weeks after the final treatment
Difference of Body Image Quality Life Inventory (BIQLI) score	Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7 point ranging from -3 (very negative) to +3 (very positive).	4 weeks after the final treatment

Collaborators and Investigators

• Sponsor: AMIpharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Polyene phosphatidylcholine
• Other Study ID Numbers: AYP-101-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No