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HealthyPhase 3NCT06256445

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

A Phase 3 study testing Polyene Phosphatidylcholine in people with Healthy, run by AMIpharm Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Polyene Phosphatidylcholine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
1 siteSouth Korea
Study dates
26 Mar 2024to 30 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males or females aged 19 to 65 (inclusive)
  • Patient with submental subcutaneous fat deposited who meet all of the following:
  • Patient with ER-SMFRS and SR-SMFRS Grade 2 (moderate) or 3 (severe) at visit 1
  • Subject Self Satisfaction Scale (SSSS) Grade 2 (slightly dissatisfied) or less at visit 1
  • Patient who has stably maintained body weight for the past 6 months (weight change within ±10% of subject's weight); agrees to refrain from exercise and diet that may affect the study result during the study period and maintain pre-study exercise/diet during the study period
  • Able to comply with the protocol visit schedule and plans
  • Voluntarily provides written informed consent

Who cannot join

  • Allergic to IP component (soy) and lidocaine or medical devices used in this clinical trial (sterile permanent marker, alcohol swab, administration site design grid pad, injection needle, etc.)
  • Has morbid obesity of central, endocrine, and genetic nature (BMI ≥ 35 kg/m2 at screening)
  • History of plastic surgery (liposuction) or injection containing phosphatidylcholine or deoxycholic acid at the planned IP administration site for the purpose of submental fat reduction or history of double jaw surgery
  • History of following procedures at the planned IP administration site
  • Thread lifting, implants, dermal fillers with active ingredient other than hyaluronic acid or collagen, or semi-permanent fillers within 12 months prior to visit 2
  • Dermal fillers with active ingredient hyaluronic acid or collagen or Botulinum toxin procedure within 6 months prior to visit 2 (including entire chin and neck area)
Show all 32Show fewer
  • Focused ultrasound, radiofrequency or cryolipolysis within 6 months prior to visit 2
  • Laser therapy, optic therapy, or chemical dermabrasion procedure within 3 months prior to visit 2
  • Deemed inappropriate for the study by the investigator, such as the following:
  • Skin at the administration site is sagging or deformed
  • Has a prominent platysmal band under the chin
  • Has a short chin; jawbone in the lower jaw developed less than normal
  • Has a condition (e.g., cervical lymphadenopathy), inflammation, wound or surgical scar in the chin or the neck that is deemed to affect study assessments
  • Has any other factors deemed to affect evaluations by the investigator (evaluator)
  • History of dysphagia or current symptoms of dysphasia
  • Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening
  • Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.)
  • Uncontrolled hypertension (sitSBP ≥180 mmHg or sitDBP ≥110 mmHg at screening)
  • Uncontrolled type 2 diabetes (HbA1c > 9% at screening) or type 1 diabetes
  • Has an autoimmune disease or receiving immunosuppressants
  • Receiving anticoagulants such as warfarin and clopidogrel or has a coagulation disorder
  • Has thyromegaly or hyperthyroidism
  • HIV-positive
  • Diagnosis of malignancy within the last 5 years
  • Severe renal dysfunction (serum creatinine > 2.0 mg/dl at screening)
  • Severe liver dysfunction (ALT, AST or ALP > upper limit of normal x 2.5 at screening)
  • A history of or currently suffering from a serious psychiatric condition (e.g., depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia)
  • Administration of drugs that may affect the body weight and lipid metabolism, such as appetite suppressants, oral steroids, thyroid hormones, amphetamines, cyproheptadine, phenothiazines or drugs that may affect absorption, metabolism and excretion within 3 months of screening
  • Receipt of any other IPs within 3 months prior to IP administration
  • Pregnant or lactating women, or subjects who are planning to become pregnant
  • Failure to agree to use a contraceptive method that is highly effective when used correctly, alone or in combination, continuously throughout the study and up to 3 months after the final IP administration
  • Deemed ineligible to be a study subject by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chung-Ang University Hosptial

    Seoul, 06973

Other trials in South Korea

About this study

Official title: 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

To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults

Read the 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
Being tested
Polyene Phosphatidylcholine, Matching placebo of AYP-101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyene PhosphatidylcholineDrug

    Also called AYP-101

    Formulated as an injectable solution containing Polyene Phosphatidylcholine at concentration of 25 mg/mL

  • Matching placebo of AYP-101Drug

    Also called Placebo

    Phosphate buffered saline placebo for injection

Study groups in NCT06256445
Study groupRoleWhat they receive
AYP-101Experimental0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments
Receives: Drug: Polyene Phosphatidylcholine
PlaceboPlacebo comparator0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments
Receives: Drug: Matching placebo of AYP-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-primary Outcome Measure 1

    Ratio of subjects with at least 1 grade improvement in both ER-SMFRS(Evaluator Reported Submental Fat Rating Scale) and SR-SMFRS(Subject Reported Submental Fat Rating Scale)

    Measured: at 12 weeks after the final administration compared to baseline

  2. Co-primary Outcome Measure 2

    Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS

    Measured: at 12 weeks after the final administration compared to baseline

Secondary outcomes (10)

  1. At least 1 grade improvement in both ER-SMFRS and SR-SMFRS

    Ratio of subjects with at least 1 grade improvement in both ER-SMFRS and SR-SMFRS

    Measured: at 4 weeks after the final administration compared to baseline

  2. At least 2 grade improvement in both ER-SMFRS and SR-SMFRS

    Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS

    Measured: at 4 weeks after the final administration compared to baseline

  3. At least 1 grade improvement in ER-SMFRS

    Ratio of subjects with at least 1 grade improvement in ER-SMFRS

    Measured: at 4 and 12 weeks after the final administration compared to baseline

  4. At least 2 grades improvement in ER-SMFRS

    Ratio of subjects with at least 2 grades improvement in ER-SMFRS

    Measured: at 4 and 12 weeks after the final administration compared to baseline

  5. At least 1 grade improvement in SR-SMFRS

    Ratio of subjects with at least 1 grade improvement in SR-SMFRS

    Measured: at 4 and 12 weeks after the final administration compared to baseline

  6. At least 2 grades improvement in SR-SMFRS

    Ratio of subjects with at least 2 grades improvement in SR-SMFRS

    Measured: at 4 and 12 weeks after the final administration compared to baseline

  7. SSSS(Subject Self Satisfaction Scale)

    Ratio of subjects with SSSS of at least 4 points

    Measured: at 4 and 12 weeks after the final administration

  8. PR-SMFIS(Patient Reported Submental Fat Impact Scale)

    Change in average PR-SMFIS score from baseline, In detail, it is a tool on which subjects measure how their submental fat looks on a scale of 0 to 10 points b y responding to 6 questions.

    Item 1 is in regard to satisfaction, and items 2 to 6 are questions in regard to dissatisfaction; all items will be calculated on a dissatisfaction scale* and mean will be calculated.

    • Item 1 dissatisfaction scale = 10 (points) - Item 1 score
    • Items 2 to 6 dissatisfaction scale = each item score

    Each item in the PR-SMFIS is scored from 0 to 10, with a higher total score indicating greater dissatisfaction.

    Measured: at 4 and 12 weeks after the final administration

  9. PGIC(Patient Global Impression of Change)

    PGIC evaluation

    Measured: at 4 and 12 weeks after the final administration

  10. 3D imaging

    Change in subject's submental fat volume by 3D imaging from baseline

    Measured: at 4 and 12 weeks after the final administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start26 Mar 2024
  3. Primary completion5 Jul 2024
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06256445
Sponsor's protocol ID
AYP-101-301
Status last verified
Jan 2026
First submitted
5 Feb 2024
Last updated
22 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Polyene Phosphatidylcholine in people with Healthy, run by AMIpharm Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-primary Outcome Measure 1 (time frame: at 12 weeks after the final administration compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06256445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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