NCT06256445

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: AMIpharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Polyene Phosphatidylcholine	Formulated as an injectable solution containing Polyene Phosphatidylcholine at concentration of 25 mg/mL
DRUG	Matching placebo of AYP-101	Phosphate buffered saline placebo for injection

Timeline

• Start date: 2024-03-26
• Primary completion: 2024-07-05
• Completion: 2025-10-30
• First posted: 2024-02-13
• Last updated: 2026-01-22

Locations

1 site across 1 country: South Korea