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To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).
Full description
This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of AYP-101 S.C injection for the reduction of SMF who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male and female over 19 and under 65 years old
Localized submental fat under chin area and who meet all the following criteria.
① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1
② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1
Stable weight over the last 6 months (body weight change within +/-10%), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period
Singed informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
96 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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