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New injection melts double chin in clinical trial

NCT ID NCT06256445

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an injection called AYP-101 to reduce fat under the chin (double chin) in 252 healthy adults aged 19 to 65. Participants received either the drug or a placebo, and doctors and patients rated fat reduction using a scale. The goal was to see if the injection safely improves chin appearance without surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

252 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females aged 19 to 65 (inclusive) 2. 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 3. 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 4. Able to comply with the protocol visit schedule and plans 5. Voluntarily provides written informed consent Exclusion Criteria: 1. 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.) 2. Has morbid obesity of central, endocrine, and genetic nature (BMI ≥ 35 kg/m2 at screening) 3. 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 4. 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) * 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 5. 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) 6. History of dysphagia or current symptoms of dysphasia 7. Diagnosis of heart disease (heart failure, unstable angina, myocardial infarction) or brain disease (stroke, cerebral hemorrhage, cerebral infarct) within 6 months of screening 8. Has a condition during this study period that requires medication with NSAIDs (arthritis, lung diseases, etc.) 9. Uncontrolled hypertension (sitSBP ≥180 mmHg or sitDBP ≥110 mmHg at screening) 10. Uncontrolled type 2 diabetes (HbA1c \> 9% at screening) or type 1 diabetes 11. Has an autoimmune disease or receiving immunosuppressants 12. Receiving anticoagulants such as warfarin and clopidogrel or has a coagulation disorder 13. Has thyromegaly or hyperthyroidism 14. HIV-positive 15. Diagnosis of malignancy within the last 5 years 16. Severe renal dysfunction (serum creatinine \> 2.0 mg/dl at screening) 17. Severe liver dysfunction (ALT, AST or ALP \> upper limit of normal x 2.5 at screening) 18. A history of or currently suffering from a serious psychiatric condition (e.g., depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia) 19. 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 20. Receipt of any other IPs within 3 months prior to IP administration 21. Pregnant or lactating women, or subjects who are planning to become pregnant 22. 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 23. Deemed ineligible to be a study subject by the investigator

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chung-Ang University Hosptial

    Seoul, 06973, South Korea

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