A Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Ic Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Participants With Overweight or Obesity

Beijing QL Biopharmaceutical Co.,Ltd1 个研究点分布在 1 个国家目标入组 28 人2023年11月21日

适应症Overweight or Obesity

干预措施ZT002 Injection Placebo

概览

阶段: 1 期
干预措施: ZT002 Injection
疾病 / 适应症: Overweight or Obesity
发起方: Beijing QL Biopharmaceutical Co.,Ltd
入组人数: 28
试验地点: 1
主要终点: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events.
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity.

注册库

clinicaltrials.gov

开始日期

2023年11月21日

结束日期

2024年10月17日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Beijing QL Biopharmaceutical Co.,Ltd

责任方

Sponsor

入排标准

入选标准

•1\. Males and females aged 18 to 50 years (inclusive, based on age at the time of signing the informed consent form);
•2\. BMI ≥ 24 kg/m2 and \< 28 kg/m2 with at least one of the following concomitant disease (pre-diabetes \[except for type 1 or type 2 diabetes\], hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome, weight-bearing joint pain, etc., see Appendices I and II) or BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 and with or without concomitant disease;
•3\. Weight change of no more than 5% (based on self-report) after 3 months of weight control via diet and exercise alone prior to screening, and the formula for calculating weight change is: (highest weight - lowest weight during 3 months of weight control via diet and exercise alone prior to screening) ∕highest weight\*100%;
•4\. Female subjects are required to adopt abstinence or 2 effective methods of contraception from 1 month prior to screening to 6 months after the last dose, and male subjects are required to adopt abstinence or 2 effective methods of contraception from the first dose to 3 months after the last dose. For male subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., vasectomy) or proper use of condoms, or the female partners use hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable) or intrauterine devices (IUDs) or surgical sterilization; for female subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., tubal ligation) or use of IUDs, or male partners properly use condoms or are surgically sterilized, in addition, the female subjects are allowed to use the NMPA-approved hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable);
•5\. Subjects who have a good understanding of study objectives, be able to communicate well with the investigator, and be able to understand and comply with the requirements set forth for this study.

排除标准

•1\. History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
•2\. Previous diagnosis of obesity associated with endocrine disease or single gene mutation, including but not limited to, hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, hypogonadism;
•3\. Subjects who have had severe gastrointestinal diseases (e.g., active ulcers) or undergone gastrointestinal surgery (except for appendectomy or cholecystectomy) or have clinically significant abnormalities of gastric emptying (e.g., pyloric obstruction, gastric paralysis) within 6 months prior to screening or have been taking medications that have a direct effect on gastrointestinal motility for a long term, or who are not suitable for participation in the trial as assessed by the investigator;
•4\. Prior history of significant cardiovascular disease, defined as:
•a) History of myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmia requiring treatment, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident within 6 months prior to screening; b) New York Heart Association (NYHA) class III or IV congestive cardiac failure;
•5\. Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
•6\. Laboratory test results at screening meet any of the following criteria (one retest is allowed during the screening period if there is any clear reason, and the investigator should document the reason for retest):
•Glycosylated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L, or two-hour plasma glucose ≥ 11.1 mmol/L on oral glucose tolerance test (OGTT) (at screening, subjects with fasting venous plasma glucose between 6.1 and 6.9 mmol/L need to perform OGTT) (see Appendix I, OGTT Test Method);
•Thyroid-stimulating hormone (TSH) \> 6.0 mIU/L or \< 0.4 mIU/L;
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × ULN or blood total bilirubin ≥ 2 × ULN;

研究组 & 干预措施

ZT002 Injection

Participants will be randomized to receive ZT002 injection in 1of 2 dose cohorts.

干预措施: ZT002 Injection

ZT002 Placebo

Participants will be randomized to receive same volume Placebo in 1 of 2 dose cohorts.

干预措施: Placebo

结局指标

主要结局

Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events.

时间窗: up to 270 days

Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events.

时间窗: up to 270 days

次要结局

The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity.(up to 270 days)
The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing.(up to 270 days)
The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity.(up to 270 days)