ChiCTR2100049968 版本V1.3 版本创建时间2022/03/15 20:09:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100049968 

最近更新日期：

Date of Last Refreshed on：

 2022-03-15 20:07:53 

注册时间：

Date of Registration：

 2021-08-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

请于伦理委员会批准后才开始征募参试者，并与我们联系上传伦理批件。 评估IBI362在肥胖或超重高尿酸血症患者中有效性和安全性的单中心、随机、双盲、安慰剂对照、2:1平行分组的临床研究

Public title：

Efficacy and safety of IBI362 in overweight or obesity patients with hyperuricemia: a single center, randomized, double-blind, placebo-controlled, 2:1 parallel clinical study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估IBI362在肥胖或超重高尿酸血症患者中有效性和安全性的单中心、随机、双盲、安慰剂对照、2:1平行分组的临床研究

Scientific title：

Efficacy and safety of IBI362 in overweight or obesity patients with hyperuricemia: a single center, randomized, double-blind, placebo-controlled, 2:1 parallel clinical study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

吕璐 

研究负责人：

姜宏卫 

Applicant：

Lu Lu 

Study leader：

Jiang Hongwei 

申请注册联系人电话：

Applicant telephone：

 +86 15136369171

研究负责人电话：

Study leader's
telephone：

+86 13653880139

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 q543373434@163.com

研究负责人电子邮件：

Study leader's E-mail：

 jianghw@haust.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 河南科技大学第一附属医院

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

河南省洛阳市洛龙区关林路636号

研究负责人通讯地址：

河南省洛阳市洛龙区关林路636号

Applicant address：

636 Guanlin Road, Luolong District, Luoyang, Henan

Study leader's address：

636 Guanlin Road, Luolong District, Luoyang, Henan

申请注册联系人邮政编码：

Applicant postcode：

 471000

研究负责人邮政编码：

Study leader's postcode：

 471000

申请人所在单位：

河南科技大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Henan University of Science and Technology

研究负责人所在单位：

河南科技大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Henan University of Science and Technology

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

河南科技大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Henan University of Science and Technology

研究实施负责（组长）单位地址：

河南省洛阳市洛龙区关林路636号

Primary sponsor's address：

636 Guanlin Road, Luolong District, Luoyang, Henan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河南

市(区县)：

洛阳

Country：

China

Province：

Henan

City：

Louyang

单位(医院)：

河南科技大学第一附属医院

具体地址：

洛龙区关林路636号

Institution
hospital：

The First Affiliated Hospital of Henan University of science and technology

Address：

636 Guanlin Road, Luolong District

经费或物资来源：

河南科技大学第一附属医院

Source(s) of funding：

The First Affiliated Hospital of Henan University of Science and Technology

研究疾病：

高尿酸血症  

Target disease：

hyperuricemia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价IBI362连续给药24周血尿酸较基线变化。  

Objectives of Study：

To evaluate the changes of blood uric acid compared with baseline after continuous administration of ibi362 for 24 weeks.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄18~60周岁（包含两端），男性或女性；
2.肥胖者：BMI≥28.0kg/m2；或超重者：24.0≤BMI＜28.0kg/m2并伴有以下至少一种表现：
(1)食欲旺盛，餐前饥饿难忍，每餐进食量较多；
(2)合并糖尿病前期（空腹血糖受损和/或糖耐量异常）、高血压、血脂异常、脂肪肝（筛选前6个月内）中的一种或几种；
(3)合并负重关节疼痛；
(4)肥胖引起呼吸困难或有阻塞性睡眠呼吸暂停综合征；
3.正常嘌呤饮食状态下，空腹血尿酸>420umol/L；
4.能够理解本研究的程序和方法，愿意严格遵守临床试验方案完成本试验，并自愿签署知情同意书。

Inclusion criteria

1. Aged 18 to 60 years (including both ends), male or female;
2. Obese: BMI>=28.0kg/m2; or overweight: 24.0<=BMI<28.0kg/m2 and accompanied by at least one of the following manifestations:
(1) Strong appetite, unbearable hunger before meals, and more food intake per meal;
(2) Combined with one or more of prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, dyslipidemia, and fatty liver (within 6 months before screening);
(3) Combined with weight-bearing joint pain;
(4) Dyspnea caused by obesity or obstructive sleep apnea syndrome;
3. Under normal purine diet, fasting blood uric acid>420umol/L;
4. Be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent.

排除标准：

1.研究者怀疑受试者可能对研究药物或成分或同类药过敏；
2.筛选前经单纯饮食运动控制至少12周的体重变化＞5.0%（主诉）；
3.继发性高尿酸血症受试者；
4.既往诊断为痛风；
5.筛选前使用以下任何一种药物或治疗：筛选前3个月内使用过GLP-1受体（GLP-1R）激动剂或GLP-1R/GCGR激动剂或GIPR/GLP-1R激动剂或GIPR/GLP-1R/GCGR激动剂；筛选前3个月内使用过降尿酸药物，包括别嘌呤醇、非布司他、苯溴马隆等；筛选前3个月内使用过对体重有影响的药物，包括：全身性的类固醇激素用药（静脉、口服或关节内给药）、三环类抗抑郁药、精神疾病用药或镇静类药物（如丙咪嗪、阿米替林、米氮平、帕罗西汀、苯乙肼、氯丙嗪、硫利达嗪、氯氮平、奥氮平、丙戊酸、丙戊酸衍生物、锂盐）等；筛选前3个月内使用过影响体重的中草药、保健品、代餐等；筛选前3个月内使用过或目前正在使用减肥药物，如：盐酸西布曲明、奥利司他、苯丁胺、苯丙醇胺、氯苯咪吲哚、芬特明、安非拉酮、氯卡色林、芬特明/托吡酯合剂、纳曲酮/安非他酮合剂等；筛选前3个月内使用过降糖药物，如二甲双胍、SGLT2抑制剂、噻唑烷二酮类（TZD）等；筛选前3个月内参加过其他临床试验（已接受试验药物治疗）；
6.有以下任何一种疾病的病史或证据：筛选时HbA1c≥6.5%或既往诊断为I型或II型糖尿病患者；筛选时空腹静脉血糖≥7.0mmol/L；既往或筛选时存在视网膜病变的患者；既往发生过严重低血糖或反复症状性低血糖（半年内≥2次）；继发疾病或药物导致肥胖，包括：皮质醇激素升高（例如：库欣综合征）、垂体和下丘脑损伤导致的肥胖、减肥药减量/停用导致的肥胖等；既往有进行过减肥手术（筛选前1年前进行过针灸减肥、抽脂术和腹部去脂术除外）；研究期间计划进行减肥手术或针灸减肥、抽脂术和腹部去脂术等；既往有过中重度抑郁症病史；或既往有严重的精神疾病史，例如：精神分裂症，双相情感障碍等；既往有自杀倾向或自杀行为；筛选前一个月内存在未稳定控制的高血压，定义为：收缩压≥160mmHg和/或舒张压≥100mmHg（如使用降压药物需稳定1个月）；既往或筛选时存在恶性肿瘤病史（已治愈的皮肤基底细胞癌和宫颈原位癌除外）；既往发生过心肌梗死，心绞痛，急慢性心力衰竭，心肌病，或进行过经皮冠状动脉介入治疗，冠状动脉旁路移植术等心脏手术或超声心动图提示心功能明显异常且研究者评估后不适合参加本研究；筛选前6个月内发生出血性或缺血性脑卒中或短暂性脑缺血发作；既往有甲状腺癌病史、MEN（多发性内分泌腺瘤病）2A或2B病史或相关家族史；既往有急慢性胰腺炎病史，胆囊病史，胰腺损伤史；存在肢体畸形或残缺，无法准确确定身高、体重等指标；筛选前1个月内有大中型手术、严重外伤、严重感染，研究者判断不适合参加本研究；试验期间有预期手术，但研究者判断对受试者安全和试验结果无影响的门诊手术除外；在筛选时人免疫缺陷病毒（HIV）抗体或丙型肝炎（HCV）抗体或梅毒抗体阳性的受试者；筛选时乙肝表面抗原（HBsAg）阳性（筛选时使用抗乙肝病毒药物不可入组）；筛选时存在酒精和药物滥用病史。平均每周酒精摄入超过14个单位，或用药日前24小时及整个研究期间不愿意停止饮酒（1单位=360ml啤酒，或150ml红酒，或45ml蒸馏酒/白酒）；
7.筛选时有任何一项实验室检查指标符合下列标准（如有明确复测理由可在一周内复测，研究者需做好复测理由的记录）：血清降钙素≥20ng/L（pg/mL）；谷丙转氨酶≥3.0×正常上限（UpperLimitofNormalValue,ULN）和/或谷草转氨酶≥3.0×ULN和/或总胆红素≥1.5×ULN；肾小球滤过率eGFR＜60mL/min/1.73m2，应用CKD-EPI公式估算（见附录3）；存在甲状腺功能异常（TSH＞6mIU/L或＜0.4mIU/L）；空腹甘油三酯≥5.64mmol/L（500mg/dl）；血淀粉酶或脂肪酶＞2.0×ULN；凝血酶原时间的国际标准化比值（INR）大于正常值范围上限；血红蛋白＜110g/L（男性）或＜100g/L（女性）；
8.筛选时12导联心电图显示心率＜50次/分或＞100次/分；
9.筛选时具有以下有临床意义的12导联心电图（ECGs）异常：II度或III度房室传导阻滞、长QT综合征或QTcF＞500ms、左或右束支传导阻滞、预激综合征或其他有意义的心律失常（窦性心律失常除外）；
10.妊娠或哺乳期女性，具有生育能力的男性或女性不愿意在整个研究期间避孕；
11.筛选前3个月内献血量和/或失血量≥400mL或进行过骨髓捐献，或存在血红蛋白病、溶血性贫血、镰状细胞性贫血；
12.研究者认为受试者具有任何可能影响本研究的疗效或安全性评价的其他因素存在，不适合参加本研究。

Exclusion criteria：

1. The investigator suspects that the subject may be allergic to the study drug or component or similar drugs. 2. The weight change after simple diet and exercise control for at least 12 weeks before screening was more than 5.0% (main complaint). 3. Subjects with secondary hyperuricemia. 4. Previous diagnosis of gout. 5. Use any of the following drugs or treatments before screening: 1) use GLP-1 receptor (GLP-1R) agonists or GLP-1R / gcgr agonists or GIPR / GLP-1R agonists or GIPR / GLP-1R / gcgr agonists within 3 months before screening; 2) Uric acid lowering drugs used within 3 months before screening, including allopurinol, febrestat, benzbromarone, etc; 3) Drugs that have an impact on body weight within 3 months before screening, including systemic steroids (intravenous, oral or intra-articular), tricyclic antidepressants, psychiatric drugs or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenylethylhydrazine, chlorpromazine, thiolidazine, clozapine, olanzapine, valproic acid Valproic acid derivatives, lithium salts, etc; 4) Chinese herbal medicine, health care products and substitute meals that affect body weight within 3 months before screening; 5) Weight loss drugs used or currently being used within 3 months before screening, such as sibutramine hydrochloride, orlistat, phenylbutylamine, phenylpropanolamine, chlorphenimiindole, fentamine, amphetamine, chlorocaseline, fentamine / topiramate mixture, naltrexone / bupropion mixture, etc; 6) Hypoglycemic drugs such as metformin, SGLT2 inhibitor and thiazolidinediones (TZD) were used within 3 months before screening; 7) Participated in other clinical trials (treated with trial drugs) within 3 months before screening. 6. there is a history or evidence of any of the following diseases: 1) when screening, HbA1c is more than 6.5% or formerly diagnosed as type I or type II diabetes. 2) Blood glucose in abdominal vein ≥ 7.0mmol/l during screening; 3) Patients with previous or screening retinopathy; 4) Severe hypoglycemia or recurrent symptomatic hypoglycemia occurred in the past (≥ 2 times in half a year); 5) Secondary diseases or drugs lead to obesity, including: increased cortisol hormone (e.g. Cushing's syndrome), obesity caused by pituitary and hypothalamic injury, obesity caused by reduction / withdrawal of weight-loss drugs, etc; 6) Previous bariatric surgery (except acupuncture, liposuction and abdominal liposuction 1 year before screening); 7) Weight loss surgery or acupuncture, liposuction and abdominal liposuction are planned during the study; 8) Previous history of moderate and severe depression; Or previous history of serious mental illness, such as schizophrenia, bipolar disorder, etc; 9) Previous suicidal tendency or suicidal behavior; 10) Hypertension without stable control in the month before screening is defined as systolic blood pressure ≥ 160mmhg and / or diastolic blood pressure ≥ 100mmhg (if antihypertensive drugs are used, it needs to be stable for 1 month); 11) A history of malignancy at the time of previous or screening (except cured skin basal cell carcinoma and cervical carcinoma in situ); 12) Previous myocardial infarction, angina pectoris, acute and chronic heart failure, cardiomyopathy, or cardiac surgery or echocardiography such as percutaneous coronary intervention and coronary artery bypass grafting suggest obvious abnormal cardiac function, and the researcher is not suitable to participate in this study after evaluation; 13) Hemorrhagic or ischemic stroke or transient ischemic attack occurred within 6 months before screening. 14) previous history of thyroid cancer, history of men 2A or 2B or related family history; 15) Previous history of acute and chronic pancreatitis, gallbladder and pancreatic injury; 16) There are limb deformities or deformities, and it is impossible to accurately determine the height, weight and other indicators; 17) There were large and medium-sized operations, serious trauma and serious infection within 1 month before screening, and the researcher judged that it was not suitable to participate in this study; 18) There were expected operations during the trial, except for outpatient operations that the investigator judged had no impact on the safety of subjects and test results; 19) Subjects who were positive for human immunodeficiency virus (HIV) antibody or hepatitis C (HCV) antibody or syphilis antibody at the time of screening; 20) screening for hepatitis B surface antigen (HBsAg) positive (screening when using anti HBV drugs can not be inserted into the group); 21) there was a history of alcohol and drug abuse at the time of screening. The average weekly intake of alcohol exceeds 14 units, or 24 hours before the medication and during the whole study period. They are unwilling to stop drinking (1 units of =360ml beer, or 150ml red wine, or 45ml distilled liquor / Baijiu). 7. During screening, any laboratory test index meets the following standards (if there is a clear reason for retest, it can be retested within one week, and the researcher shall make a record of the reason for retest): 1) serum calcitonin ≥ 20ng / L (PG / ml); 2) Alanine aminotransferase ≥ 3.0 × Upper limit of normal value (ULN) and / or aspartate aminotransferase ≥ 3.0 × ULN and / or total bilirubin ≥ 1.5 × ULN 3) Glomerular filtration rate EGFR < 60ml / min / 1.73m2, estimated by CKD-EPI formula (see Appendix 3); 4) Thyroid dysfunction (TSH > 6miu / L or < 0.4miu / L); 5) Fasting triglyceride ≥ 5.64mmol/l (500mg / dl); 6) Blood amylase or lipase > 2.0 × ULN 7) The international normalized ratio (INR) of prothrombin time was greater than the upper limit of the normal range; 8) Hemoglobin < 110g / L (male) or < 100g / L (female). 8. During screening, 12 lead ECG showed that the heart rate was less than 50 beats / min or more than 100 beats / min; 9. 12 lead electrocardiogram (ECG) abnormalities with the following clinical significance during screening: degree II or III atrioventricular block, long QT syndrome or QTCF > 500ms, left or right bundle branch block, preexcitation syndrome or other meaningful arrhythmias (except sinus arrhythmias); 10. Pregnant or lactating women, fertile men or women are unwilling to use contraception throughout the study period; 11. Blood donation and / or blood loss ≥ 400ml or bone marrow donation within 3 months before screening, or hemoglobinopathy, hemolytic anemia and sickle cell anemia; 12. The researcher believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2021-08-01 00:00:00至 To 2022-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-08-16 00:00:00 至 To 2022-08-01 00:00:00

干预措施：

Interventions：

组别：

1组

样本量：

 52

Group：

group 1

Sample size：

干预措施：

IBI362药物

干预措施代码：

Intervention：

IBI362 drug

Intervention code：

组别：

2组

样本量：

 26

Group：

group 2

Sample size：

干预措施：

空白对照

干预措施代码：

Intervention：

Blank control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 洛阳 

Country：

China

Province：

Henan

City：

Louyang

单位(医院)：

 河南科技大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Henan University of science and technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

尿酸

指标类型：

主要指标

Outcome：

uric acid

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用区组随机的方法将受试者按照 2：1 比例随机分配至每个剂量组中IBI362 组和安慰剂组。受试者随机化由 IWRS 完成，成功随机的受试者将获得一个随机编号，并按系统分配的药物编号获得药物治疗。由非盲统计师完成受试者随机编号和药物编号的编盲工作，传输至随机系统非盲管理员以完成 IWRS 设盲准备和管理工作。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The subjects were randomly assigned to ibi362 group and placebo group in each dose group according to the ratio of 2:1. The randomization of subjects is completed by IWRS. The successful randomized subjects will receive a random number and receive drug treatment according to the drug number assigned by

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://yfy.haust.edu.cn/

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://yfy.haust.edu.cn/

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

为病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2021-08-15 04:43:52