ChiCTR2400090260 版本V1.0 版本创建时间2024/09/26 14:58:03 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：

 ChiCTR2400090260 

最近更新日期：

Date of Last Refreshed on：

 2024-09-26 14:57:53 

注册时间：

Date of Registration：

 2024-09-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价ABP2111Na片在2型糖尿病患者中随机、双盲、安慰剂对照的单次、多次给药剂量递增的安全性、耐受性、药代动力学及药效动力学特征的Ib期临床试验

Public title：

Phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ABP2111Na tablets in randomized, double-blind, placebo-controlled single and multiple administration dose escalation in patients with type 2 diabetes mellitus

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价ABP2111Na片在2型糖尿病患者中随机、双盲、安慰剂对照的单次、多次给药剂量递增的安全性、耐受性、药代动力学及药效动力学特征的Ib期临床试验

Scientific title：

Phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ABP2111Na tablets in randomized, double-blind, placebo-controlled single and multiple administration dose escalation in patients with type 2 diabetes mellitus

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：

王海平 

研究负责人：

李晓丽 / 周焕 

Applicant：

Haiping Wang 

Study leader：

Xiaoli Li / Huan Zhou 

申请注册联系人电话：

Applicant telephone：

 +86 133 8158 8683

研究负责人电话：

Study leader's
telephone：

+86 136 6552 7160

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：

 hpwang@zannan.com

研究负责人电子邮件：

Study leader's E-mail：

 158169847@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

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：

上海市闵行区光中路133弄99号

研究负责人通讯地址：

安徽省蚌埠市龙子湖区长淮路287 号

Applicant address：

99 Lane133 Guangzhong RD, Shanghai, P.R. China

Study leader's address：

287 Changhuai Road, Longzihu District, Bengbu, Anhui, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海爱博医药科技有限公司

Applicant's institution：

Shanghai AB PharmaTech Ltd.

研究负责人所在单位：

蚌埠医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Bengbu Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 蚌医一附院临床医学研究伦理审[2024]238号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

蚌埠医学院第一附属医院临床医学研究伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Bengbu Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-19 00:00:00

伦理委员会联系人：

段丽莎

Contact Name of the ethic committee：

Lisha Duan

伦理委员会联系地址：

安徽省蚌埠市龙子湖区长淮路287号

Contact Address of the ethic committee：

287 Changhuai Road, Longzihu District, Bengbu, Anhui, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 552 308 6046

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：

蚌埠医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Bengbu Medical University

研究实施负责（组长）单位地址：

安徽省蚌埠市龙子湖区长淮路287 号

Primary sponsor's address：

287 Changhuai Road, Longzihu District, Bengbu, Anhui, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

上海市

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海爱博医药科技有限公司

具体地址：

上海市闵行区光中路133弄99号

Institution
hospital：

Shanghai AB PharmaTech Ltd.

Address：

99 Lane133 Guangzhong RD, Shanghai, China

经费或物资来源：

上海爱博医药科技有限公司

Source(s) of funding：

Shanghai AB PharmaTech Ltd.

研究疾病：

2型糖尿病  

Target disease：

Type 2 diabetes

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 评价2型糖尿病患者单次与多次口服ABP2111Na片的安全性和耐受性，为本品在II期2型糖尿病患者中的研究推荐剂量范围； 次要目的： 1. 评价2型糖尿病患者单次与多次口服ABP2111Na片的药代动力学（PK）特征； 2. 评价2型糖尿病患者单次与多次口服ABP2111Na片的药效动力学（PD）特征。 探索性目的： 1. 初步评价2型糖尿病患者口服ABP2111Na片的有效性； 2. 在高剂量组评估ABP2111Na片在2型糖尿病患者中的心脏安全性。  

Objectives of Study：

Primary Objective: To evaluate the safety and tolerability of single versus multiple oral doses of ABP2111Na tablets in patients with type 2 diabetes mellitus, and to recommend a dose range for a study of this product in patients with stage II type 2 diabetes mellitus; Secondary Objectives: 1. To evaluate the pharmacokinetic (PK) profile of single versus multiple oral doses of ABP2111Na tablets in patients with type 2 diabetes; 2. To evaluate the pharmacodynamic (PD) profile of single versus multiple oral doses of ABP2111Na tablets in patients with type 2 diabetes. Exploratory Objectives: 1. To preliminarily evaluate the efficacy of oral administration of ABP2111Na tablets in patients with type 2 diabetes mellitus; 2. To assess the cardiac safety of ABP2111Na tablets in patients with type 2 diabetes mellitus in a high-dose group.

药物成份或治疗方案详述：

本次试验合计纳入30例成年2型糖尿病患者（包括初治患者及既往经二甲双胍规范治疗后疗效不佳的患者，二甲双胍剂量为：二甲双胍剂量≥1500mg/日或为受试者最大耐受剂量），男女比例适当。剂量组暂定为3个剂量组，每个剂量组10例，其中8例试验组，2例安慰剂组。拟从25mg、50mg开始进行剂量递增研究，第3个剂量组根据前两个剂量组的安全性、PK/PD和初步疗效进行确定。 

Description for medicine or protocol of treatment in detail：

A total of 30 adult patients with type 2 diabetes mellitus (including patients with primary treatment and patients with poor outcome after previous standardized treatment with metformin at a metformin dose of >=1500 mg/day or at the subject's maximum tolerated dose) were enrolled in this trial, with an appropriate male-to-female ratio. The dose groups were tentatively set at 3 dose groups of 10 patients each, with 8 in the test group and 2 in the placebo group. Dose-escalation studies are proposed to start at 25 mg and 50 mg, with the 3rd dose group being determined based on the safety, PK/PD, and preliminary efficacy of the first two dose groups. 

纳入标准：

符合以下所有条件者，才能入组： 1. 18周岁至65周岁（含边界值），男女比例适当； 2. 体重指数（BMI＝体重（kg）/身高2（m2））在18.0~32 kg/m2之间(含边界值)，且体重≥45kg； 3. 根据1999年WHO标准确诊为2型糖尿病； 4. 经饮食、运动干预等干预后，7.0%≤糖化血红蛋白（HbA1c）≤10.5%，且空腹血糖（FPG）≤13.9 mmol/L；接受单一的稳定治疗8周的二甲双胍治疗者（稳定剂量，二甲双胍剂量≥1500mg/日或为受试者最大耐受剂量）（HbA1c的入排确认以当地医院的检测结果为准）； 5. 本研究每个剂量组优先纳入２型糖尿病合并非酒精性脂肪性肝病（NAFLD）受试者，MRI-PDFF示肝脏脂肪含量≥8%（接受随机前28天内在本试验中心进行的MRI-PDFF检查结果）； 6. 同意本研究期间不使用任何除研究药物外的其他降糖药物； 7. 自愿参加并签署《知情同意书》。

Inclusion criteria

Enrollment is only possible if all of the following conditions are met: 1. Between 18 and 65 years of age (including borderline values), with an appropriate male to female ratio; 2. Body mass index (BMI = weight (kg)/height^2 (m^2)) between 18.0 and 32 kg/m^2 (including borderline values) and weighing >=45 kg; 3. Diagnosed with type 2 diabetes mellitus according to the 1999 WHO criteria; 4. 7.0% <= glycated hemoglobin (HbA1c) <= 10.5% and fasting blood glucose (FPG) <= 13.9 mmol/L after dietary and exercise interventions and other interventions; those who were treated with a single stable treatment of metformin for 8 weeks (stable dose, metformin dosage >= 1500 mg/day or the maximum tolerated dose of the subject) (the confirmation of the entry row of HbA1c was based on the local hospital test results); 5. Priority enrollment in each dose group of this study will be given to subjects with type 2 diabetes mellitus combined with non-alcoholic fatty liver disease (NAFLD) with >=8% hepatic fat content as shown by MRI-PDFF (results of MRI-PDFF performed at the trial center within 28 days prior to randomization will be accepted); 6. Agree not to use any glucose-lowering medication other than the study drug during this study; 7. Voluntarily participate and sign the Informed Consent Form.

排除标准：

符合以下条件之一者，不能入组： 1. 有过敏史者或已知对本品的任何组分过敏者； 2. 1型糖尿病、单基因突变糖尿病或继发性糖尿病，如库欣综合征或肢端肥大症、胰腺损伤引起的糖尿病患者；有其它未良好控制的内分泌系统疾病（如甲亢、甲减、皮质醇增多症）者；但可以纳入患有除2型糖尿病以外的慢性疾病（例如高胆固醇血症），但通过饮食或稳定剂量药物治疗得到控制的患者（例如可入选接受适当治疗的高胆固醇血症患者）； 3. 筛选前1个月内正在使用胰岛素促泌剂（磺脲类药物和格列奈类药物）和/或胰岛素和/或GLP-1激动剂进行降糖治疗者； 4. 筛选前6个月内出现过急性代谢并发症（酮症酸中毒、有临床意义的酮症、乳酸性酸中毒或高渗性昏迷状态）； 5. 存在或既往存在可能影响受试者安全或研究结果判定的血液学疾病、肿瘤、肾脏疾病、内分泌疾病、肺部疾病、胃肠道疾病、心血管疾病、肝脏疾病、精神病、神经系统疾病； 6. 既往有增殖性视网膜病史和黄斑病史者； 7. 既往甲状腺髓样癌（MTC）或2型多发性内分泌瘤综合征（MEN2）病史或家族史，或降钙素≥50 pg/ml； 8. 目前存在感染，需要系统给药控制感染者； 9. 吞咽困难，或有影响胃肠道吸收的疾病（如炎症性肠病、活动性溃疡），或研究者评估为增加用药后风险的胃肠道疾病（如胃食管反流病、急性胃肠炎、症状性慢性胃肠炎、功能性胃肠病、肠结核等），或接受过可导致吸收不良的胃肠道手术，或长期接受对胃肠蠕动有影响的药物/治疗[如接受过减肥手术或操作（如胃束带术）]者； 10. 筛选时正在使用减肥药物或计划在研究期间服用减肥药物，或在筛选前3个月内服用过减肥药者，或筛选前3个月内体重变化超过10%者； 11. 既往有症状的胆囊疾病、胰腺癌、急性或慢性胰腺炎病史，或筛选时患有急性或慢性胰腺炎； 12. 筛选前3个月内发生过2次及以上的严重低血糖事件； 13. 既往有失代偿性心力衰竭病史（NYHA分级为III和IV），半年内有不稳定性心绞痛、中风或短暂性脑缺血发作、持续性且有临床意义的心律失常（如频发性期前收缩）病史者；有高血压病史，且应用稳定剂量的（至少4周）降压药物治疗后收缩压（SBP）≥150 mmHg和/或舒张压（DBP）≥90 mmHg； 14. 筛选时12导联ECG显示可能影响受试者安全或研究结果解读的临床相关异常（例如，男性QTcF≥450 ms、女性≥470 ms者、完全左束支传导阻滞（LBBB）、急性或急慢性不明的心肌梗死体征、提示心肌缺血的ST段变化、二度或三度房室传导阻滞或严重的缓慢性心律失常或快速性心律失常。如果QTcF超过450msec或QRS超过120msec，则应再重复2次ECG，并使用3个QTcF或QRS值的平均值确定受试者的资格； 15. 实验室检查项符合以下任一标准：淀粉酶＞1.5×ULN、甘油三酯≥5.7 mmol/L（500 mg/dL）、eGFR<60 mL/min/1.73m2（根据简化MDRD公式计算）、血红蛋白≤100 g/L、谷丙转氨酶（ALT）、谷草转氨酶（AST）、总胆红素（TBIL）≥1.5×ULN；对于２型糖尿病合并非酒精性脂肪性肝病（NAFLD）受试者，AST>3倍正常上限（ULN），ALT>3倍ULN，总胆红素（TBIL）≥1.5×ULN； 16. 筛选前3个月内做过大型手术，或在试验期间至结束后一个月内计划接受手术者； 17. 筛选前3个月内有献血或大量失血者（≥400 mL）或输血或输入血制品者； 18. 给药前3个月内参加其他任何临床试验者； 19. 给药前2天或试验期间不禁烟酒，饮用含黄嘌呤或咖啡因的饮料（如巧克力、咖啡、茶、可乐等），进行剧烈运动，或有其他影响药物吸收、分布、代谢、排泄因素者； 20. 筛选前3个月内有酒精滥用史[每周饮用酒精超过14个单位者(1单位≈360mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒)]；或筛选时、或入院时酒精呼气研究检测阳性者； 21. 筛选前3个月内，每天吸烟超过5支或摄入与之等量的尼古丁或尼古丁替代品； 22. 首次给药前尿药筛阳性者或有药物滥用史（如吗啡、大麻、甲基安非他明、二亚甲基双氧安非他明、氯胺酮等）； 23. 筛选访视时人类免疫缺陷病毒（HIV）抗体检测阳性或乙肝病毒感染者、丙型肝炎抗体、梅毒螺旋体抗体检查阳性； 24. 不能够依从研究者制定的治疗方案和糖尿病饮食运动方案，不愿意或不能够进行自我血糖监测者； 25. 筛选前1个月内或计划在试验期间接种疫苗者； 26. 存在精神疾病史或当前存在精神疾病、存在中重度或重度抑郁状态，或认为有重大自杀风险； 27. 哺乳期妇女，以及男性受试者（或其伴侣）或女性受试者在研究前30天至研究结束后6个月内有妊娠计划或捐精、捐卵计划，不愿采取有效的避孕措施者；筛选期间血清妊娠检查结果阳性者； 28. 研究者判断，患者依从性差，或其他原因不适合参加本临床试验者。

Exclusion criteria：

Persons who meet one of the following conditions are not eligible for enrollment: 1. Persons with a history of allergy or known hypersensitivity to any component of the product; 2. Persons with type 1 diabetes mellitus, diabetes mellitus with a single gene mutation, or diabetes mellitus secondary to a disease such as Cushing's syndrome or acromegaly, or diabetes mellitus due to pancreatic injury; and persons with other endocrine system disorders that are not well-controlled (e.g., hyperthyroidism, hypothyroidism, and hypercortisolism); provided, however, that patients who have a chronic disease other than type 2 diabetes mellitus (e.g., hypercholesterolemia) but are treated with a diet or a stabilized dose of medication may be enrolled controlled (e.g., may enroll patients with hypercholesterolemia who are receiving appropriate treatment); 3. Those who are on glucose-lowering therapy with insulinotropic agents (sulfonylureas and glinides) and/or insulin and/or GLP-1 agonists within 1 month prior to screening; 4. Acute metabolic complications (ketoacidosis, clinically significant ketosis, lactic acidosis, or hyperosmolar comatose state) within 6 months prior to screening; 5. Presence or history of hematological disorders, neoplasms, renal disorders, endocrine disorders, pulmonary disorders, gastrointestinal disorders, cardiovascular disorders, hepatic disorders, psychiatric disorders, and neurological disorders that may affect subject safety or determination of study results; 6. Prior history of proliferative retinopathy and macular disease; 7. Prior history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or calcitonin >= 50 pg/ml; 8. Presence of current infection requiring systemic administration of medication for infection control; 9. Dysphagia, or a condition that interferes with gastrointestinal absorption (e.g., inflammatory bowel disease, active ulcers), or a gastrointestinal condition that is assessed by the investigator as an increased risk for post-dose administration (e.g., gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.), or who have undergone gastrointestinal surgery that can lead to malabsorption or who have received long-term medications/treatments that have an effect on gastrointestinal motility [ such as those who have undergone bariatric surgery or operations (e.g. gastric banding)]; 10. Persons who are on weight loss medication at screening or plan to take weight loss medication during the study, or who have taken weight loss medication within 3 months prior to screening, or who have had a change in weight of more than 10% in the 3 months prior to screening; 11. Prior history of symptomatic gallbladder disease, pancreatic cancer, acute or chronic pancreatitis, or acute or chronic pancreatitis at screening; 12. Two or more episodes of severe hypoglycemia within 3 months prior to screening; 13. A history of decompensated heart failure (NYHA classification III and IV); a history of unstable angina pectoris, stroke or transient ischemic attack, or persistent and clinically significant cardiac arrhythmia (e.g., frequent preterm systole) within 6 months; a history of hypertension with a systolic blood pressure (SBP) >=150 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg after application of a stable dose (at least 4 weeks) of antihypertensive medication; 14. 12-lead ECG at screening showing clinically relevant abnormalities that may affect subject safety or interpretation of study results (e.g., QTcF ≥450 ms in men and ≥470 ms in women, complete left bundle branch block (LBBB), signs of acute or acute or chronic unspecified myocardial infarction, ST-segment changes suggestive of myocardial ischemia, second- or third-degree AV block, or severe bradyarrhythmias or tachyarrhythmias). arrhythmia or tachyarrhythmia. If the QTcF exceeds 450 msec or the QRS exceeds 120 msec, the ECG should be repeated 2 additional times and the average of the 3 QTcF or QRS values used to determine subject eligibility; 15. Laboratory test items that meet any of the following criteria: amylase >1.5 x ULN, triglycerides >=5.7 mmol/L (500 mg/dL), eGFR <60 mL/min/1.73m2 (based on the simplified MDRD formula), hemoglobin <=100 g/L, alanine aminotransferase (ALT), azelaic aminotransferase (AST), total bilirubin ( TBIL) >=1.5 × ULN; for subjects with type 2 diabetes mellitus combined with nonalcoholic fatty liver disease (NAFLD), AST >3 times upper limit of normal (ULN), ALT >3 times ULN, and total bilirubin (TBIL) >=1.5 × ULN; 16. Those who have had major surgery within 3 months prior to screening or are scheduled to undergo surgery during the trial period through one month after completion; 17. Persons who have donated blood or have had significant blood loss (>=400 mL) or who have had a blood transfusion or imported blood products within 3 months prior to screening; 18. Participation in any other clinical trial within 3 months prior to administration; 19. Those who are not abstaining from tobacco or alcohol, consuming xanthine or caffeine containing beverages (e.g., chocolate, coffee, tea, cola, etc.), engaging in strenuous exercise, or have other factors that affect drug absorption, distribution, metabolism, or excretion 2 days prior to administration or during the trial period; 20. History of alcohol abuse within 3 months prior to screening [persons who consume more than 14 units of alcohol per week (1 unit ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol by volume or 150 mL of wine)]; or persons who have tested positive on an alcohol breath study at the time of screening, or at the time of admission to the hospital; 21. Smoking more than 5 cigarettes per day or ingesting an equivalent amount of nicotine or nicotine replacement within 3 months prior to screening; 22. Persons with a positive urine drug screen or a history of substance abuse (e.g., morphine, marijuana, methamphetamine, MDMA, ketamine, etc.) prior to the first drug administration; 23. Positive Human Immunodeficiency Virus (HIV) antibody test or positive Hepatitis B virus infection, Hepatitis C antibody, or Syphilis spirochete antibody test at the screening visit; 24. Unable to comply with the treatment plan and diabetic diet and exercise program established by the investigator, and unwilling or unable to perform self-monitoring of blood glucose; 25. Persons who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the trial; 26. A history of or current mental illness, the presence of a moderately severe or major depressive state, or a perceived significant risk of suicide; 27. Women who are breastfeeding, and male subjects (or their partners) or female subjects who have a pregnancy plan or a plan for sperm or egg donation within 30 days prior to the study and up to 6 months after the end of the study and who are unwilling to use effective contraception; and those who have a positive serum pregnancy test result during screening; 28. Those who, in the judgment of the investigator, have poor patient compliance or are otherwise unsuitable for participation in this clinical trial.

研究实施时间：

Study execute time：

从 From 2024-09-25 00:00:00至 To 2027-09-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-26 00:00:00 至 To 2027-09-25 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 24

Group：

Experimental group

Sample size：

干预措施：

剂量递增阶段：ABP2111Na片连续28天给药，拟从25 mg、50 mg开始进行剂量递增研究，第3个剂量组根据前两个剂量组的安全性、PK/PD和初步疗效进行确定。 疗效探索阶段（仅适用于选定的剂量组）： 治疗期：受试者完成4周的多次给药观察后，由研究者根据受试者的安全性、PK/PD和初步疗效判定其获益情况，若受试者获益则维持原给药方案继续治疗至给药后12周，以探索ABP2111Na的初步疗效。暂定在25mg和50mg剂量组进行研究，本研究最终采用的剂量组将根据试验中的具体情况决定。

干预措施代码：

Intervention：

Dose Escalation Phase: ABP2111Na tablets were administered for 28 consecutive days, with dose-escalation studies proposed to begin at 25 mg and 50 mg, with the 3rd dose group determined based on the safety, PK/PD, and preliminary efficacy of the first two dose groups. Efficacy Exploration Phase (for selected dose groups only): after subjects have completed 4 weeks of multiple dosing observations, benefit will be determined by the investigator based on safety, PK/PD, and preliminary efficacy, and if subjects benefit then the original dosing regimen will be maintained to continue treatment until 12 weeks post dosing to explore the preliminary efficacy of ABP2111Na. Studies are tentatively scheduled to be conducted in the 25 mg and 50 mg dose groups, and the final dose group to be used in this study will be determined on a trial-by-trial basis.

Intervention code：

组别：

安慰剂组

样本量：

 6

Group：

Placebo group

Sample size：

干预措施：

ABP2111Na安慰剂片连续28天给药，拟从25 mg、50 mg开始进行剂量递增研究，第3个剂量组根据前两个剂量组的安全性、PK/PD和初步疗效进行确定。

干预措施代码：

Intervention：

ABP2111Na placebo tablets were administered for 28 consecutive days in a proposed dose-escalation study starting at 25 mg, 50 mg, with the 3rd dose group determined based on safety, PK/PD and preliminary efficacy of the first two dose groups.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

 蚌埠市 

Country：

China

Province：

Anhui

City：

Bengbu prefecture level city

单位(医院)：

 蚌埠医学院第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Bengbu Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性和耐受性

指标类型：

主要指标

Outcome：

Safety and tolerability

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学（PK）特征

指标类型：

次要指标

Outcome：

Pharmacokinetic (PK) profile

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药效动力学（PD）特征

指标类型：

次要指标

Outcome：

Pharmacodynamic (PD) profile

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

BMI、体重、腰围、腰臀比和空腹血脂水平变化

指标类型：

次要指标

Outcome：

Changes in BMI, weight, waist circumference, waist-to-hip ratio and fasting lipid levels

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心脏安全性（浓度-QTc间期）

指标类型：

次要指标

Outcome：

Cardiac safety (concentration-QTc intervals)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

MRI-PDFF测量的肝脂肪分数

指标类型：

次要指标

Outcome：

Hepatic fat fraction measured by MRI-PDFF

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

HbA1c的变化

指标类型：

次要指标

Outcome：

Changes in HbA1c

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血糖、胰岛素、C肽、胰高血糖素及胰高血糖素样肽-1（包括总GLP-1和活性 GLP-1）等

指标类型：

次要指标

Outcome：

Blood glucose, insulin, C-peptide, glucagon, and glucagon like peptide-1 (including total GLP-1 and active GLP-1), etc.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胰岛细胞功能变化

指标类型：

次要指标

Outcome：

Changes in insulin cell function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胰岛素生成指数变化

指标类型：

次要指标

Outcome：

Changes in insulin production indices

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胰岛素抵抗指数（HOMA-IR）变化

指标类型：

次要指标

Outcome：

Change in insulin resistance index (HOMA-IR)

Type：

Secondary 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：

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 65 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）：

每个剂量组单独筛选，筛选成功者将进行随机，未随机者可参与下一剂量组的筛选。 在每个剂量组内，每名受试者的分组将由随机方案确定。随机方案由统计单位应用SAS软件（9.4或更高版本）随机产生。在筛选时，每名受试者将使用筛选号进行识别，以S+五位阿拉伯数字表示，前2位为中心号（01、02、……），后3位为顺序号（001、002、……），如S02001表示02中心的第1个参加筛选者。在研究药物给药前一天进行随机化。随机号由4位数组成，第1位表示剂量组，1、2、3分别表示25mg、50mg、待定剂量组，第2-4位代表随机的顺序号，比如2001表示这是50mg组第1例随机的受试者。 本研究计划在多个中心开展，随机号以及药物号的分配采用中央随机系统实现。受试者筛选成功之后，由研究者登陆中央随机系统为其申请随机号，随机号申请之后即已完成了入组，然后继续向中央随机系统申请药物编号，药物管理员将对应编号的药物发放给该患者即可完成随机。

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

Each dose group will be screened individually; those who are successful in screening will be randomized, and those who are not randomized may participate in the next dose group. Within each dose group, the grouping of each subject will be determined by a randomization scheme. The randomization scheme will be generated randomly by the statistical unit applying SAS software (version 9.4 or higher). At the time of screening, each subject will be identified using a screening number, expressed as S + five Arabic numerals, with the first 2 digits being the center number (01, 02, ......), and the last 3 digits being the sequential number (001, 002, ......), e.g., S02001 indicates that 1st participant of 02 center for screening. Randomization was performed one day before study drug administration. The randomization number consists of 4 digits, with the 1st digit indicating the dose group, 1, 2, and 3 for the 25 mg, 50 mg, and to-be-determined dose groups, respectively, and the 2nd-4th digits representing the sequential number of the randomization, e.g., 2001 indicates that this is the 1st subject randomized in the 50 mg group. This study was planned to be conducted in multiple centers and the assignment of randomization numbers as well as drug numbers was achieved using a centralized randomization system. After a subject has been screened, the investigator logs into the central randomization system to request a randomization number for him or her. After the randomization number has been requested, enrollment is completed, and then the drug number is requested from the central randomization system, and the drug administrator will distribute the drug with the corresponding number to the patient to complete the randomization.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

研究者和受试者均盲

Blinding：

Investigators and subjects were blinded

是否共享原始数据：

IPD sharing

是Yes

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）：

预计2027年09月 临床试验公共管理平台 ResMan IPD（http://www.medresman.org.cn）

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

September 2027, ResMan IPD(http://www.medresman.org.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：

CRF和ResMan

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

CRF and ResMan

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：

  2024-09-26 14:57:53