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Not yet recruiting NCT07697846

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

Phase I Interventional Overweight, Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZT002 injection, ZT002 injection matching placebo.
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change to baseline- and placebo-corrected QTc interval (ΔΔQTc) [Time frame: Up to Day 141]
Secondary outcome measures (12)
  • Effect of ZT002 plasma concentrations on heart rate (HR) [Time frame: Up to Day 141]
  • Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF) [Time frame: Up to Day 141]
  • Effect of ZT002 plasma concentrations on PR interval [Time frame: Up to Day 141]
  • Effect of ZT002 plasma concentrations on QRS complex duration [Time frame: Up to Day 141]
  • Effect of ZT002 plasma concentrations on T wave [Time frame: Up to Day 141]
  • Effect of ZT002 plasma concentrations on U wave [Time frame: Up to Day 141]
  • PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h) [Time frame: Up to Day 141]
  • PK parameter analysis of ZT002 for peak concentration (Cmax) [Time frame: Up to Day 141]
  • PK parameter analysis of ZT002 for time to peak concentration (Tmax) [Time frame: Up to Day 141]
  • Incident of anti-drug antibody against ZT002 [Time frame: Up to Day 141]
  • Incidence of adverse events (AEs) [Time frame: Up to Day 141]
  • Change in body weight (kg) [Time frame: Up to Day 141]

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) <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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing GoBroad Hospital — Beijing

Identifiers

NCT: NCT07697846 · BJQL-ZT002-1008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗