NCT05266729

Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area

A Single Center, Randomized, Placebo Controlled Phase Ⅱ Study to Determine the Dosing Interval and the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: AMIpharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).

Detailed 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.

Conditions

• Moderate or Severe Submental Fullness

Interventions

Type	Name	Description
DRUG	Polyene Phosphatidylcholine	Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
DRUG	Placebo	Phosphate buffered saline placebo for injection

Timeline

• Start date: 2022-03-02
• Primary completion: 2022-12-28
• Completion: 2023-02-20
• First posted: 2022-03-04
• Last updated: 2023-08-15

Locations

1 site across 1 country: South Korea