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

NCT03982225 | Completed Phase 2 DMC

• 1 other identifier: AYP-101-201
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Moderate or Severe Submental Fullness

Keywords

Apoptosis; Lipolysis; Fat reduction; Submental fat; Polyene Phosphatidylcholine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline

  A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.

  Baseline and 12 weeks after last treatment

Secondary Outcomes (11)

• Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline

  Baseline and 12 weeks after last treatment

• Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline

  Baseline and 12 weeks after last treatment

• Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area

  Baseline and 12 weeks after last treatment

• Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area

  Baseline and 12 weeks after last treatment

• Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline

  Baseline and 12 weeks after last treatment

Study Arms (4)

2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm

EXPERIMENTAL

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.

Drug: Polyene phosphatidylcholine injection

5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm

EXPERIMENTAL

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.

Drug: Polyene phosphatidylcholine injection

5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm

EXPERIMENTAL

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.

Drug: Polyene phosphatidylcholine injection

Placebo 0.2 mL/1.0 cm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Polyene phosphatidylcholine injection 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

2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm; 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm; 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm

Placebo DRUG

Phosphate buffered saline placebo for injection

Placebo 0.2 mL/1.0 cm

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.
• 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.
• 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.
• 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.
• Signed informed consent obtained before any study-specific procedure is performed.

You may not qualify if:

• Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
• Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
• Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
• Unable to undergo MRI by neurosis or general weakness.
• History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
• History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
• Inflammation, scars or surgery on the injection area.
• 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.
• Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
• 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.

Sponsors & Collaborators

• AMIpharm Co., Ltd.: lead

Study Sites (4)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, 06273, 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 Officials

• Dae Hyeon Lew, MD,PhD

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 11, 2019
• Study Start: July 1, 2019
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)