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

Phase 3

Recruiting

• Conditions: Healthy
• Interventions: Drug: Polyene Phosphatidylcholine; Drug: Matching placebo of AYP-101

• Registration Number: NCT06256445
• Lead Sponsor: AMIpharm Co., Ltd.

Brief Summary

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

Detailed Description

This study is to evaluate efficacy and safety of AYP-101 S.C injection for the reduction of Submental Fat who wish improvement in the appearance of moderate to severe convexity or fullness associated with Submental Fat in adults

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Status Verified: 2024-03
• Study Start: 2024-03-26
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-08-07
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AYP-101	Polyene Phosphatidylcholine	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
Placebo	Matching placebo of AYP-101	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

Primary Outcome Measures

Name	Time	Method
Co-primary Outcome Measure 2	at 12 weeks after the final administration compared to baseline	Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS
Co-primary Outcome Measure 1	at 12 weeks after the final administration compared to baseline	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)

Secondary Outcome Measures

Name	Time	Method
At least 2 grade improvement in both ER-SMFRS and SR-SMFRS	at 4 weeks after the final administration compared to baseline	Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS
At least 1 grade improvement in ER-SMFRS	at 4 and 12 weeks after the final administration compared to baseline	Ratio of subjects with at least 1 grade improvement in ER-SMFRS
At least 1 grade improvement in SR-SMFRS	at 4 and 12 weeks after the final administration compared to baseline	Ratio of subjects with at least 1 grade improvement in SR-SMFRS
At least 1 grade improvement in both ER-SMFRS and SR-SMFRS	at 4 weeks after the final administration compared to baseline	Ratio of subjects with at least 1 grade improvement in both ER-SMFRS and SR-SMFRS
At least 2 grades improvement in ER-SMFRS	at 4 and 12 weeks after the final administration compared to baseline	Ratio of subjects with at least 2 grades improvement in ER-SMFRS
SSSS(Subject Self Satisfaction Scale)	at 4 and 12 weeks after the final administration	Ratio of subjects with SSSS of at least 4 points
3D imaging	at 4 and 12 weeks after the final administration	Change in subject's submental fat volume by 3D imaging from baseline
At least 2 grades improvement in SR-SMFRS	at 4 and 12 weeks after the final administration compared to baseline	Ratio of subjects with at least 2 grades improvement in SR-SMFRS
PGIC(Patient Global Impression of Change)	at 4 and 12 weeks after the final administration	PGIC evaluation
PR-SMFIS(Patient Reported Submental Fat Impact Scale)	at 4 and 12 weeks after the final administration	Change in average PR-SMFIS score from baseline, In detail, it is a tool on which subjects measure how their submental fat looks on a scale of 0 to 10 points b y responding to 6 questions.; Item 1 is in regard to satisfaction, and items 2 to 6 are questions in regard to dissatisfaction; all items will be calculated on a dissatisfaction scale\* and mean will be calculated.; * Item 1 dissatisfaction scale = 10 (points) - Item 1 score; * Items 2 to 6 dissatisfaction scale = each item score

Trial Locations

Locations (1)

Chung-Ang University Hosptial; 🇰🇷 Seoul, Heukseok-ro, Dongjak-gu, Korea, Republic of