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NCT Number: NCT07697846

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing GoBroad Hospital

Beijing, 102200, China

Location contact

Quankun Zhuang, Master

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZT002 Injection

Drug

Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.

ZT002 injection matching placebo

Drug

Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.

Primary outcomes

  1. Change to baseline- and placebo-corrected QTc interval (ΔΔQTc)

    Time frame: Up to Day 141

    Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling.

Secondary outcomes

  1. Effect of ZT002 plasma concentrations on heart rate (HR)

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on HR

  2. Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF)

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on QTcF;

  3. Effect of ZT002 plasma concentrations on PR interval

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on PR interval

  4. Effect of ZT002 plasma concentrations on QRS complex duration

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on QRS complex duration

  5. Effect of ZT002 plasma concentrations on T wave

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on T wave

  6. Effect of ZT002 plasma concentrations on U wave

    Time frame: Up to Day 141

    Measure the Effect of ZT002 plasma concentrations on U wave

  7. PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h)

    Time frame: Up to Day 141

  8. PK parameter analysis of ZT002 for peak concentration (Cmax)

    Time frame: Up to Day 141

  9. PK parameter analysis of ZT002 for time to peak concentration (Tmax)

    Time frame: Up to Day 141

  10. Incident of anti-drug antibody against ZT002

    Time frame: Up to Day 141

  11. Incidence of adverse events (AEs)

    Time frame: Up to Day 141

  12. Change in body weight (kg)

    Time frame: Up to Day 141

  13. Change in Body Mass Index (BMI) (kg/m²)

    Time frame: Up to Day 141

  14. Change in waist circumference (cm)

    Time frame: Up to Day 141

  15. Change in hip circumference (cm)

    Time frame: Up to Day 141

  16. Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%)

    Time frame: Up to Day 141

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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