ZT002 injection: Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
ZT002 injection matching placebo: Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Change to baseline- and placebo-corrected QTc interval (ΔΔQTc) — Up to Day 141 Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling.
Trial sites (1)
Facility
City
Region
Status
Beijing GoBroad Hospital
Beijing
China
More Beijing QL Biopharmaceutical Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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