Reducing chin fat with AYP-101 injections

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅲ Clinical Study to Evaluate Efficacy and Safety of AYP-101 for the Reduction of Submental Fat in Adults

This study is testing if AYP-101 injections can help adults reduce chin fat and feel better about their appearance.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: AMIpharm Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Seoul, Heukseok-ro, Dongjak-gu)
• Trial ID: NCT06256445 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of AYP-101, a subcutaneous injection, for reducing submental fat in adults who have moderate to severe fullness in the chin area. Participants will receive either the active treatment or a matching placebo while maintaining their weight and lifestyle during the study. The trial aims to assess improvements in appearance and patient satisfaction related to submental fat reduction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 65 with moderate to severe submental fat who are dissatisfied with their appearance.

Not a fit: Patients with allergies to the study components or those with morbid obesity may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a non-surgical option for individuals seeking to improve the appearance of their chin and neck area.

How similar studies have performed: Other studies have shown promising results with similar injectable treatments for fat reduction, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged 19 to 65 (inclusive)
2. 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
3. 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
4. Able to comply with the protocol visit schedule and plans
5. Voluntarily provides written informed consent

Exclusion Criteria:

1. 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.)
2. Has morbid obesity of central, endocrine, and genetic nature (BMI ≥ 35 kg/m2 at screening)
3. 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
4. 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
5. 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)
6. History of dysphagia or current symptoms of dysphasia
7. Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening
8. Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.)
9. Uncontrolled hypertension (sitSBP ≥180 mmHg or sitDBP ≥110 mmHg at screening)
10. Uncontrolled type 2 diabetes (HbA1c \> 9% at screening) or type 1 diabetes
11. Has an autoimmune disease or receiving immunosuppressants
12. Receiving anticoagulants such as warfarin and clopidogrel or has a coagulation disorder
13. Has thyromegaly or hyperthyroidism
14. HIV-positive
15. Diagnosis of malignancy within the last 5 years
16. Severe renal dysfunction (serum creatinine \> 2.0 mg/dl at screening)
17. Severe liver dysfunction (ALT, AST or ALP \> upper limit of normal x 2.5 at screening)
18. A history of or currently suffering from a serious psychiatric condition (e.g., depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia)
19. Administration of drugs that may affect the body weight and lipid metabolism, such as appetite suppressants, oral steroids, thyroid hormones, amphetamines, cyproheptadine, phenothiazines or drugs that may affect absorption, metabolism and excretion within 3 months of screening
20. Receipt of any other IPs within 3 months prior to IP administration
21. Pregnant or lactating women, or subjects who are planning to become pregnant
22. Failure to agree to use a contraceptive method that is highly effective when used correctly, alone or in combination, continuously throughout the study and up to 3 months after the final IP administration
23. Deemed ineligible to be a study subject by the investigator

Where this trial is running

Seoul, Heukseok-ro, Dongjak-gu

• Chung-Ang University Hosptial — Seoul, Heukseok-ro, Dongjak-gu, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Beomjoon Kim, MD — Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Study coordinator: Ki Taek Lee, CEO

Conditions Healthy