A Study to Investigate the Effects of Zovaglutide (ZT002 Injection) on QTc Interval in Healthy Adults

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

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.

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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