보고서 정보
주관연구기관 |
(주)다림바이오텍 |
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2009-11 |
과제시작연도 |
2009 |
주관부처 |
보건복지가족부 Ministry for Health, Welfare and Family Affairs |
등록번호 |
TRKO201400022325 |
과제고유번호 |
1355060098 |
사업명 |
보건의료기술연구개발 |
DB 구축일자 |
2014-11-22
|
키워드 |
비만.임상연구.알파리포산.나노약물.Obesity.clinical study.alpha-lipoic acid.nano-drug.
|
초록
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본 연구는 항비만효과를 예비 연구에서 증명한 alpha-lipoic acid의 2, 3 상 임상연구를 통해 유효성과 안전성을 입증하고 2) 메디컬 나노기술을 이용하여 부작용을 극소화한 alpha-lipoic acid 나노약물을 개발하고자 하였다. Alpha-lipoic acid의 항비만효과에 대한 임상 2상 a, b 연구가 성공적으로 완료되어 1,800 mg의 alpha-lipoic acid 치료시 대조군에 비해 3 배이상의 체중감소를 보였으며, 이에 대하여 식약청 보고 및 3상 허가에 대한 계획서를 제출 예정이다. 기존의 약에 비
본 연구는 항비만효과를 예비 연구에서 증명한 alpha-lipoic acid의 2, 3 상 임상연구를 통해 유효성과 안전성을 입증하고 2) 메디컬 나노기술을 이용하여 부작용을 극소화한 alpha-lipoic acid 나노약물을 개발하고자 하였다. Alpha-lipoic acid의 항비만효과에 대한 임상 2상 a, b 연구가 성공적으로 완료되어 1,800 mg의 alpha-lipoic acid 치료시 대조군에 비해 3 배이상의 체중감소를 보였으며, 이에 대하여 식약청 보고 및 3상 허가에 대한 계획서를 제출 예정이다. 기존의 약에 비해 효능을 극대화시키고 부작용을 최소화할 수 있는 alpha-lipoic acid nano-durg의 개발 및 이의 세포 및 동물 실험을 통해 그 효능을 확인하였으며, 주관 참여기업에서 이에 대한 대량생산 과정을 확립하여 임상 1상 연구 계획을 진행중이다.
Abstract
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I. Purpose and necessity of the research
The goal of this study was to evaluate the efficacy and safety of alpha-lipoic acid, drug proven anti-obesity effect and to develop and commercialize nano-drug, which minimized side effects of alpha-lipoic acid using nanotechnology.
II. Details and scop
I. Purpose and necessity of the research
The goal of this study was to evaluate the efficacy and safety of alpha-lipoic acid, drug proven anti-obesity effect and to develop and commercialize nano-drug, which minimized side effects of alpha-lipoic acid using nanotechnology.
II. Details and scope of the research
○ Phase II and phase III study of alpha-lipoic acid in the treatment of obese patients
○ Deve lopme nt of nano-drug, which minimizied side effects and maximized efficacy of alpha-lipoic acid
○ Cell & animal experiment and clinical trial for evaluation of the efficacy and safety of nano-drug
○ Mass production and commercializaition of alpha-lipoic acid nano-drug
III. Results
1. Completion of double-blind , multice nte r, ra ndomiz ed, para lle l, p lacebo-co ntrolle d, dose-response, phase II study evaluating the efficacy and safety of alpha-lipoic acid in the treatment of obese patients
1) Phase IIA study
① Evaluation of efficacy
- Sixty seven patients excluding 124 patients withdrawn were completed this study.
- In the 1800mg group, the percentage weight loss was 3.5%, as compared with 1.2% in the placebo group. A dose dependent effect on the percentage weight loss of alpha-lipoic acid (3.3% in 1200mg group vs 1.6% in 600mg group) was observed.
- Waist circumference, body mass index (BMI), percent body fat (PBF) were significantly decreased in alpha-lipoic acid 1800mg group. Because we did not get a minimum sample size of 20 patients per group, this trial had not a statistical power.
2) A 20-week, double-blind, multicenter, randomized, parallel, placebo-controlled, dose-response, phase II study evaluating the efficacy and safety of alpha-lipoic acid in the treatment of obese patients
- This study was conducted at 3 centers: Asan Medical Center, Kyungpook National University Hospital, and Seoul National University Bundang Hospital.
- Of the 500 patients collected in the study, 120 were randomized to 1200mg alpha-lipoic acid, 120 to 1800mg alpha-lipoic acid, and 120 to placebo.
- In the 1800mg group, the percentage weight loss was more than 2.3% compared with the placebo group. The final report will be filed and submitted to the KFDA. Thereafter, phase III comparison of alpha-lipoic acid 1800mg vs. sibutramine in obese patients is under consideration.
2. Development of alpha-lipoic acid nano-drug for the treatment of metabolic syndrome
1) Step I
- Establishment of the feasibility by building of processing equipment and manufacture of nanoparticles
- Productivity of manufacture of nanoparticles by assessment of various process parameters and impact of excipients
- Creation of patents through effective combination of the voluntary and involuntary process from the previous year and manufacture of nanoparticles with effective internal structure by using patents
- Confirmation of the effect and safety of nanoparticles by skeletal muscle cell and animal experiment
2) Step II
- Establishment of the process and optimization of the change in manufacturing process
- Augmentation of manufacturing yield of the nanoparticles
- Analysis of the changes in particles shape and size according to various processing variables
- Control of alpha-lipoic acid polymer for increased stability and bioavailability
- Assessment of industrial potential of the alpha-lipoic acid nano-drug
- Establishment of mass production process of the alpha-lipoic aicd nano-drug with participating compaany and plan to conduction of phase I study
IV. Plan of practical application of the research
Our research team has a first patent right for anti-obesity effect of alpha-lipoic acid. If we completed this phase II study and finished phase III study successfully in 2 to 3 years, the alpha-lipoic acid nano-drug will be available commercially in Korea and internationally as soon as possible. This nano-drug will be safe anti-obesity drug and have little side effects.
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