Evaluate the Efficacy and Safety of AYP-101 for the Reduction of Submental Fat in Chin Area

NCT06256445 | Completed Phase 3

• 1 other identifier: AYP-101-301
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Co-primary Outcome Measure 1

  Ratio of subjects with at least 1 grade improvement in both ER-SMFRS(Evaluator Reported Submental Fat Rating Scale) and SR-SMFRS(Subject Reported Submental Fat Rating Scale)

  at 12 weeks after the final administration compared to baseline

• Co-primary Outcome Measure 2

  Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS

  at 12 weeks after the final administration compared to baseline

Secondary Outcomes (10)

• At least 1 grade improvement in both ER-SMFRS and SR-SMFRS

  at 4 weeks after the final administration compared to baseline

• At least 2 grade improvement in both ER-SMFRS and SR-SMFRS

  at 4 weeks after the final administration compared to baseline

• At least 1 grade improvement in ER-SMFRS

  at 4 and 12 weeks after the final administration compared to baseline

• At least 2 grades improvement in ER-SMFRS

  at 4 and 12 weeks after the final administration compared to baseline

• At least 1 grade improvement in SR-SMFRS

  at 4 and 12 weeks after the final administration compared to baseline

Study Arms (2)

AYP-101

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: Matching placebo of AYP-101

Interventions

Polyene Phosphatidylcholine DRUG

Formulated as an injectable solution containing Polyene Phosphatidylcholine at concentration of 25 mg/mL

Also known as: AYP-101

AYP-101

Matching placebo of AYP-101 DRUG

Phosphate buffered saline placebo for injection

Also known as: Placebo

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:

• Males or females aged 19 to 65 (inclusive)
• Patient with submental subcutaneous fat deposited who meet all of the following:
• Patient with ER-SMFRS and SR-SMFRS Grade 2 (moderate) or 3 (severe) at visit 1
• Subject Self Satisfaction Scale (SSSS) Grade 2 (slightly dissatisfied) or less at visit 1
• Patient who has stably maintained body weight for the past 6 months (weight change within ±10% of subject's weight); agrees to refrain from exercise and diet that may affect the study result during the study period and maintain pre-study exercise/diet during the study period
• Able to comply with the protocol visit schedule and plans
• Voluntarily provides written informed consent

You may not qualify if:

• Allergic to IP component (soy) and lidocaine or medical devices used in this clinical trial (sterile permanent marker, alcohol swab, administration site design grid pad, injection needle, etc.)
• Has morbid obesity of central, endocrine, and genetic nature (BMI ≥ 35 kg/m2 at screening)
• History of plastic surgery (liposuction) or injection containing phosphatidylcholine or deoxycholic acid at the planned IP administration site for the purpose of submental fat reduction or history of double jaw surgery
• History of following procedures at the planned IP administration site
• Thread lifting, implants, dermal fillers with active ingredient other than hyaluronic acid or collagen, or semi-permanent fillers within 12 months prior to visit 2
• Dermal fillers with active ingredient hyaluronic acid or collagen or Botulinum toxin procedure within 6 months prior to visit 2 (including entire chin and neck area)
• Focused ultrasound, radiofrequency or cryolipolysis within 6 months prior to visit 2
• Laser therapy, optic therapy, or chemical dermabrasion procedure within 3 months prior to visit 2
• Deemed inappropriate for the study by the investigator, such as the following:
• Skin at the administration site is sagging or deformed
• Has a prominent platysmal band under the chin
• Has a short chin; jawbone in the lower jaw developed less than normal
• Has a condition (e.g., cervical lymphadenopathy), inflammation, wound or surgical scar in the chin or the neck that is deemed to affect study assessments
• Has any other factors deemed to affect evaluations by the investigator (evaluator)
• History of dysphagia or current symptoms of dysphasia

Sponsors & Collaborators

• AMIpharm Co., Ltd.: lead

Study Sites (1)

Chung-Ang University Hosptial

Seoul, 06973, South Korea

Location

MeSH Terms

Interventions

polyene phosphatidylcholine

Study Officials

• Beomjoon Kim, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 26, 2024
• Primary Completion: July 5, 2024
• Study Completion: October 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)