NCT06256445CompletedPhase 3
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
AMIpharm Co., Ltd.1 site in 1 country252 target enrollmentStarted: March 26, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Co-primary Outcome Measure 2
Study Overview
Brief Summary
To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double Masking
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •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
Arms & Interventions
AYP-101
Experimental
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
Intervention: Polyene Phosphatidylcholine (Drug)
Placebo
Placebo Comparator
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
Intervention: Matching placebo of AYP-101 (Drug)
Outcomes
Primary Outcomes
Co-primary Outcome Measure 2
Time Frame: at 12 weeks after the final administration compared to baseline
Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS
Co-primary Outcome Measure 1
Time Frame: at 12 weeks after the final administration compared to baseline
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)
Secondary Outcomes
- At least 1 grade improvement in ER-SMFRS(at 4 and 12 weeks after the final administration compared to baseline)
- At least 1 grade improvement in both ER-SMFRS and SR-SMFRS(at 4 weeks after the final administration compared to baseline)
- At least 2 grade improvement in both ER-SMFRS and SR-SMFRS(at 4 weeks after the final administration compared to baseline)
- At least 2 grades improvement in ER-SMFRS(at 4 and 12 weeks after the final administration compared to baseline)
- At least 1 grade improvement in SR-SMFRS(at 4 and 12 weeks after the final administration compared to baseline)
- At least 2 grades improvement in SR-SMFRS(at 4 and 12 weeks after the final administration compared to baseline)
- SSSS(Subject Self Satisfaction Scale)(at 4 and 12 weeks after the final administration)
- PR-SMFIS(Patient Reported Submental Fat Impact Scale)(at 4 and 12 weeks after the final administration)
- PGIC(Patient Global Impression of Change)(at 4 and 12 weeks after the final administration)
- 3D imaging(at 4 and 12 weeks after the final administration)
Investigators
Study Sites (1)
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