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

NCT05266729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-08-15

No results posted yet for this study

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).

Conditions

  • Moderate or Severe Submental Fullness

Interventions

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

Sponsors & Collaborators

  • AMIpharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2022-12-28
Completion
2023-02-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05266729 on ClinicalTrials.gov