CompletedPhase 2

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

South Korea143 participantsStarted 2019-07-01

Plain-language 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.

Who can participate

Age range

19 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female over 19 and under 65 years old.
. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
. Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion criteria

. Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
. Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
. Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
. Unable to undergo MRI by neurosis or general weakness.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline

Timeframe: Baseline and 12 weeks after last treatment

Trial details

NCT IDNCT03982225

SponsorAMIpharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-21

View on ClinicalTrials.gov More Moderate or Severe Submental Fullness trials