CompletedPhase 3

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

South Korea252 participantsStarted 2024-03-26

Plain-language summary

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

Age range19 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males or females aged 19 to 65 (inclusive)
✓. Patient with submental subcutaneous fat deposited who meet all of the following:
✓. 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

✕. 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
✕. Deemed inappropriate for the study by the investigator, such as the following:
✕. History of dysphagia or current symptoms of dysphasia
✕. Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening
✕. Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.)

Co-primary Outcome Measure 1

Timeframe: at 12 weeks after the final administration compared to baseline

Co-primary Outcome Measure 2

Timeframe: at 12 weeks after the final administration compared to baseline

NCT IDNCT06256445

SponsorAMIpharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-05

Who can participate

Age range19 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males or females aged 19 to 65 (inclusive)
✓. Patient with submental subcutaneous fat deposited who meet all of the following:
✓. 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

✕. 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
✕. Deemed inappropriate for the study by the investigator, such as the following:
✕. History of dysphagia or current symptoms of dysphasia
✕. Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening
✕. Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.)