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NCT07697846
A Study to Investigate the Effects of Zovaglutide (ZT002 Injection) on QTc Interval in Healthy Adults
Conditions: Overweight, Obesity
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
Location: Beijing GoBroad Hospital Beijing China
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 Criteria
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) \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
Source: ClinicalTrials.gov (NCT07697846). StuddyBuddy aggregates publicly available trial information.