NCT07697846尚未招募1 期
Phase 1, Single-Center, Randomized, Double-Blind, Parallel-Group Placebo-Controlled（Concentration）-QTc（C-QTc）Study to Evaluate the Impact of ZT002 Injection on QTc Interval in Chinese Overweight and Obese Subjects
Beijing QL Biopharmaceutical Co.,Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change to baseline- and placebo-corrected QTc interval (ΔΔQTc)
研究概览
简要总结
This study is designed to investigate the effect of treatment with Zovaglutide (ZT002 Injection) on the corrected cardiac QT interval relative to a placebo control in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- •Age between 18 - 45 years (both inclusive) at the time of signing of the informed consent;
- •Male (body weight >60.0 kg) or female (body weight >55.0 kg). Body mass index (BMI) 24.0 - 35.0 kg/m²(both inclusive);
排除标准
- •Known hypersensitivity (asthma, hypersensitivity to GLP-1 receptor agonists or excipients), or known hypersensitivity to ZT002 injection;
- •History of acute or chronic pancreatitis, or pancreatic injury.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- •Has a history of cardiovascular diseases or risk factors predisposing to torsades de pointes (TdP); has personal or family history of any cardiac conduction abnormalities; has personal or family history of long QT syndrome (LQTS); or has a family history of sudden cardiac death.
- •Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- •Medical history of hypoglycemia within 6 months before screening;
- •History of acute or chronic pancreatitis;
- •ECG findings exceeding thresholds at screening or prior to randomization: PR interval >220 ms, QRS duration >110 ms, heart rate (HR) <50 bpm or >100 bpm, QTcF ≥450 ms; or presence of any ECG abnormalities deemed clinically significant by the investigator.
- •Glycated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening;
- •Aspartate aminotransferase > 2 × upper limit of normal (ULN), Alanine aminotransferase > 2 × ULN,
- •Alkaline phosphatase total bilirubin > 1.5 × ULN;
- •Subjects who have previously undergone gastric bariatric surgery or other weight-loss surgeries, or who plan to receive weight-loss surgery, liposuction, abdominal lipectomy, or other procedures with substantial impacts on body weight during the study.
- •Use of weight-altering medications or therapies within 3 months prior to screening.
- •Administration of any medications known to prolong QT/QTc interval, alter heart rate, or carry risks of torsades de pointes (TdP) within 4 weeks prior to screening
- •Pregnant or lactating women, or subjects with a positive pregnancy test result at screening/baseline
研究组 & 干预措施
cohort2 ZT002 injection matching placebo
Experimental
Participants will receive 8 matching placebo interventions. The interventions will be administered during treatment periods starting on Days 1, 15, 29, 43, 57, 71, 85 and 99.
干预措施: ZT002 injection matching placebo (Drug)
cohort1 ZT002 injection
Experimental
Participants will receive 8 study interventions. The study interventions will be administered during treatment periods starting on Days 1, 15, 29, 43, 57, 71, 85 and 99.
干预措施: ZT002 injection (Drug)
结局指标
主要结局
Change to baseline- and placebo-corrected QTc interval (ΔΔQTc)
时间窗: Up to Day 141
Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling.
次要结局
- Effect of ZT002 plasma concentrations on heart rate (HR)(Up to Day 141)
- Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF)(Up to Day 141)
- Effect of ZT002 plasma concentrations on U wave(Up to Day 141)
- Effect of ZT002 plasma concentrations on PR interval(Up to Day 141)
- Effect of ZT002 plasma concentrations on QRS complex duration(Up to Day 141)
- Effect of ZT002 plasma concentrations on T wave(Up to Day 141)
- PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h)(Up to Day 141)
- PK parameter analysis of ZT002 for peak concentration (Cmax)(Up to Day 141)
- PK parameter analysis of ZT002 for time to peak concentration (Tmax)(Up to Day 141)
- Incident of anti-drug antibody against ZT002(Up to Day 141)
- Incidence of adverse events (AEs)(Up to Day 141)
- Change in body weight (kg)(Up to Day 141)
- Change in Body Mass Index (BMI) (kg/m²)(Up to Day 141)
- Change in waist circumference (cm)(Up to Day 141)
- Change in hip circumference (cm)(Up to Day 141)
- Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%)(Up to Day 141)
研究者
研究点 (1)
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