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

NCT05266729 | Completed Phase 2

• 1 other identifier: AYP-101-202
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Moderate or Severe Submental Fullness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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)

  12 weeks after the final treatment

• Percentage of subjects who improved at least 1 grade of Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)

  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)

  4 and 12 weeks after the final treatment

• Volume difference of pre-platysmal submental fat around chin area

  4 weeks after the final treatment

• Volume difference of platysmal submental fat around chin area

  4 weeks after the final treatment

Study Arms (3)

AYP-101 1

EXPERIMENTAL

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

AYP-101 2

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Polyene Phosphatidylcholine DRUG

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

Also known as: AYP-101

AYP-101 1; AYP-101 2

Placebo DRUG

Phosphate buffered saline placebo for injection

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AMIpharm Co., Ltd.: lead

Study Sites (1)

Chung Ang University Hospital

Seoul, 06973, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

polyene phosphatidylcholine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 4, 2022
• Study Start: March 2, 2022
• Primary Completion: December 28, 2022
• Study Completion: February 20, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)