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Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat

NCT03982225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-08-15

No results posted yet for this study

Summary

Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.

Conditions

  • Moderate or Severe Submental Fullness

Interventions

DRUG

Polyene phosphatidylcholine injection

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

Principal Investigators

  • Dae Hyeon Lew, MD,PhD · Yonsei University Health System, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-10-21
Completion
2022-10-21

Countries

  • South Korea

Study Locations

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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 NCT03982225 on ClinicalTrials.gov