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出境医 / 临床实验 / Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat (AYP-101)

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Moderate or Severe Submental Fullness Drug: Polyene phosphatidylcholine injection Drug: Placebo Phase 2

Detailed Description:
This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101

Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101

Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm
Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101

Placebo Comparator: Placebo 0.2 mL/1.0 cm
Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Placebo
Phosphate buffered saline placebo for injection

Outcome Measures
Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline and 12 weeks after last treatment ]

    A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale:

    0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.



Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]

    The CR-SMFRS is defined as at least a 1-grade improvement is evaluated by independent assessor from Baseline using the following scale:

    0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.


  2. Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]

    The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4):

    0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.


  3. Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area [ Time Frame: Baseline and 12 weeks after last treatment ]
    Change rate of reduction in pre-platysmal volume.

  4. Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area [ Time Frame: Baseline and 12 weeks after last treatment ]
    Change rate of reduction in platysmal volume.

  5. Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]

    A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale:

    0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.


  6. Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response [ Time Frame: Baseline and 12 weeks after last treatment ]

    A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.

    The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.


  7. Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Patients are asked to rate the visual and emotional impact that the appearance of submental fullness had on their self-perception using 11-point scale range from 0 (no impact) to 10 (extreme impact).

  8. Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner [ Time Frame: Baseline and 12 weeks after last treatment ]
    The cervical mental angle is measured using a 3D scanner photograph obtained at first and last visit.

  9. Patient Global Impression of Change scale (PGIC) [ Time Frame: 12 weeks after last treatment ]
    Patient global impression of change scale (PGIC) is to rate patients total improvement or worsening in the appearance since before the first treatment compared to final treatment with 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.

  10. Change From Baseline in Derriford Appearance Scale 24 (DAS24) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Difference of Derriford Appearance Scale 24 (DAS24) is to measure distress and dysfunction to problems of appearance with 24 questions using 4-point from 0 (None) to 4 (more distress).

  11. Change From Baseline in Body Image Quality of Life Inventory (BIQLI) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7-point ranging from -3 (very negative) to +3 (very positive).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female over 19 and under 65 years old.
  2. 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.
  3. 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.
  4. 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.
  5. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  1. Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
  2. Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
  3. Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
  4. Unable to undergo MRI by neurosis or general weakness.
  5. History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
  6. History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
  7. Inflammation, scars or surgery on the injection area.
  8. 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.
  9. Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
  10. History of or present symptoms of dysphagia.
  11. Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
  12. Requiring treatment of joint inflammation or a lung disease.
  13. Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%).
  14. Type 1 diabetes mellitus who needs insulin treatment.
  15. Autoimmune disorder as well as those who takes immunodepressant drugs.
  16. Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
  17. Thyromegaly, thyrotoxicosis, or HIV-positive.
  18. Diagnosed with malignant tumor within the last 5 years.
  19. Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase > maximum rate of normality x 2.5).
  20. History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
  21. 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.
  22. History of other clinical trial studies within 3 months before screening.
  23. Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
  24. Judged to be unsuitable subject for the clinical trials.
  25. No or unable to using Smart phone to fill in the e-Pro.
  26. Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ki Taek Lee +82-2-3473-1830 amikt@amipharm.com
Contact: Ji Hyun Park +82-2-3473-1830 amijh@amipharm.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13620
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Yonsei University Health System, Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Sponsors and Collaborators
AMIpharm Co., Ltd.
Investigators
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Principal Investigator: Dae Hyeon Lew, MD,PhD Yonsei University Health System, Severance Hospital
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
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 [ Time Frame: Baseline and 12 weeks after last treatment ]
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]
    The CR-SMFRS is defined as at least a 1-grade improvement is evaluated by independent assessor from Baseline using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
  • Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]
    The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4): 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
  • Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area [ Time Frame: Baseline and 12 weeks after last treatment ]
    Change rate of reduction in pre-platysmal volume.
  • Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area [ Time Frame: Baseline and 12 weeks after last treatment ]
    Change rate of reduction in platysmal volume.
  • Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline [ Time Frame: Baseline and 12 weeks after last treatment ]
    A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
  • Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response [ Time Frame: Baseline and 12 weeks after last treatment ]
    A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
  • Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Patients are asked to rate the visual and emotional impact that the appearance of submental fullness had on their self-perception using 11-point scale range from 0 (no impact) to 10 (extreme impact).
  • Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner [ Time Frame: Baseline and 12 weeks after last treatment ]
    The cervical mental angle is measured using a 3D scanner photograph obtained at first and last visit.
  • Patient Global Impression of Change scale (PGIC) [ Time Frame: 12 weeks after last treatment ]
    Patient global impression of change scale (PGIC) is to rate patients total improvement or worsening in the appearance since before the first treatment compared to final treatment with 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.
  • Change From Baseline in Derriford Appearance Scale 24 (DAS24) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Difference of Derriford Appearance Scale 24 (DAS24) is to measure distress and dysfunction to problems of appearance with 24 questions using 4-point from 0 (None) to 4 (more distress).
  • Change From Baseline in Body Image Quality of Life Inventory (BIQLI) [ Time Frame: Baseline and 12 weeks after last treatment ]
    Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7-point ranging from -3 (very negative) to +3 (very positive).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
Official Title  ICMJE A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
Brief 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.
Detailed Description This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate or Severe Submental Fullness
Intervention  ICMJE
  • Drug: Polyene phosphatidylcholine injection
    Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
    Other Name: AYP-101
  • Drug: Placebo
    Phosphate buffered saline placebo for injection
Study Arms  ICMJE
  • Experimental: 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
    Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
    Intervention: Drug: Polyene phosphatidylcholine injection
  • Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
    Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
    Intervention: Drug: Polyene phosphatidylcholine injection
  • Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm
    Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
    Intervention: Drug: Polyene phosphatidylcholine injection
  • Placebo Comparator: Placebo 0.2 mL/1.0 cm
    Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female over 19 and under 65 years old.
  2. 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.
  3. 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.
  4. 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.
  5. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  1. Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
  2. Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
  3. Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
  4. Unable to undergo MRI by neurosis or general weakness.
  5. History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
  6. History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
  7. Inflammation, scars or surgery on the injection area.
  8. 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.
  9. Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
  10. History of or present symptoms of dysphagia.
  11. Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
  12. Requiring treatment of joint inflammation or a lung disease.
  13. Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%).
  14. Type 1 diabetes mellitus who needs insulin treatment.
  15. Autoimmune disorder as well as those who takes immunodepressant drugs.
  16. Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
  17. Thyromegaly, thyrotoxicosis, or HIV-positive.
  18. Diagnosed with malignant tumor within the last 5 years.
  19. Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase > maximum rate of normality x 2.5).
  20. History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
  21. 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.
  22. History of other clinical trial studies within 3 months before screening.
  23. Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
  24. Judged to be unsuitable subject for the clinical trials.
  25. No or unable to using Smart phone to fill in the e-Pro.
  26. Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ki Taek Lee +82-2-3473-1830 amikt@amipharm.com
Contact: Ji Hyun Park +82-2-3473-1830 amijh@amipharm.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982225
Other Study ID Numbers  ICMJE AYP-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AMIpharm Co., Ltd.
Study Sponsor  ICMJE AMIpharm Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dae Hyeon Lew, MD,PhD Yonsei University Health System, Severance Hospital
PRS Account AMIpharm Co., Ltd.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP