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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат ZT002 injection
  Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
• Препарат ZT002 injection matching placebo
  Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.

Первичные конечные точки

• Change to baseline- and placebo-corrected QTc interval (ΔΔQTc) [Срок оценки: Up to Day 141]

Вторичные конечные точки (12)

• Effect of ZT002 plasma concentrations on heart rate (HR) [Срок оценки: Up to Day 141]
• Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF) [Срок оценки: Up to Day 141]
• Effect of ZT002 plasma concentrations on PR interval [Срок оценки: Up to Day 141]
• Effect of ZT002 plasma concentrations on QRS complex duration [Срок оценки: Up to Day 141]
• Effect of ZT002 plasma concentrations on T wave [Срок оценки: Up to Day 141]
• Effect of ZT002 plasma concentrations on U wave [Срок оценки: Up to Day 141]
• PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h) [Срок оценки: Up to Day 141]
• PK parameter analysis of ZT002 for peak concentration (Cmax) [Срок оценки: Up to Day 141]
• PK parameter analysis of ZT002 for time to peak concentration (Tmax) [Срок оценки: Up to Day 141]
• Incident of anti-drug antibody against ZT002 [Срок оценки: Up to Day 141]
• Incidence of adverse events (AEs) [Срок оценки: Up to Day 141]
• Change in body weight (kg) [Срок оценки: Up to Day 141]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing GoBroad Hospital — Пекин

Идентификаторы

NCT: NCT07697846 · BJQL-ZT002-1008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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