Clinical trial · Interventional
Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area
A Single Center, Randomized, Placebo Controlled Phase Ⅱ Study to Determine the Dosing Interval and the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
NCT05266729CI-TRIAL-00068826completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate or Severe Submental Fullness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Polyene Phosphatidylcholine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AYP-101 1
- description
- 0.2 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.
- interventionNames
- Drug: Polyene Phosphatidylcholine
- type
- EXPERIMENTAL
- label
- AYP-101 2
- description
- 0.2 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.
- interventionNames
- Drug: Polyene Phosphatidylcholine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female over 19 and under 65 years old * Localized submental fat under chin area and who meet all the following criteria. ① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1 ② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1 * Stable weight over the last 6 months (body weight change within +/-10%), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period * Singed informed consent Exclusion Criteria: * Allergic to beans, components of the clinical drug, or medical devices which used in this clinical trial (lidocaine, acetaminophen, sterile oil pan, alcohol swab, grid pad, needle, etc.) * Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more) * History of any treatment (orthognathic surgery, suction lipectomy, PPC or DCA injection) in the neck or chin area * History of any treatment such as mesotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling with in 1 year, and a botox surgery within 6 months before screening * Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal ④ Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy, Inflammation, scars, or surgery on the injection area * History of or present symptoms of dysphagia * Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening * Requiring treatment of joint inflammation or a lung disease * Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c\> 9%) * Type 1 diabetes mellitus who needs insulin treatment * Autoimmune disorder as well as those who takes immunodepressant drugs * Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel * Thyromegaly, thyrotoxicosis, or HIV-positive * Diagnosed with malignant tumor within the last 5 years * Severe renal dysfunction (serum creatinine \> 2.0 mg/dl) or severe dyshepatia (ALT, AST, alkaline phosphatase \> maximum rate of normality x 2.5) * History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.) * History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening * History of other clinical trial studies within 6 months before screening * Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, IUCD, spermicide, condoms etc.) * Judged to be unsuitable subject for the clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.