Overweight, Obesity
Conditions
Brief 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.
Interventions
DRUGZT002 injection
Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
DRUGZT002 injection matching placebo
Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.
Sponsors
Beijing QL Biopharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ZT002 plasma concentrations on heart rate (HR) | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on HR |
| Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF) | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on QTcF; |
| Effect of ZT002 plasma concentrations on PR interval | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on PR interval |
| Effect of ZT002 plasma concentrations on QRS complex duration | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on QRS complex duration |
| Effect of ZT002 plasma concentrations on T wave | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on T wave |
| Effect of ZT002 plasma concentrations on U wave | Up to Day 141 | Measure the Effect of ZT002 plasma concentrations on U wave |
| PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h) | Up to Day 141 | — |
| PK parameter analysis of ZT002 for peak concentration (Cmax) | Up to Day 141 | — |
| PK parameter analysis of ZT002 for time to peak concentration (Tmax) | Up to Day 141 | — |
| Incident of anti-drug antibody against ZT002 | Up to Day 141 | — |
| Incidence of adverse events (AEs) | Up to Day 141 | — |
| Change in body weight (kg) | Up to Day 141 | — |
| Change in Body Mass Index (BMI) (kg/m²) | Up to Day 141 | — |
| Change in waist circumference (cm) | Up to Day 141 | — |
| Change in hip circumference (cm) | Up to Day 141 | — |
| Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%) | Up to Day 141 | — |
Countries
China
Contacts
CONTACTLi Liu
PRINCIPAL_INVESTIGATORQuankun Zhuang, Doctor
Beijing GoBroad Hospital
PRINCIPAL_INVESTIGATORXuemei Liu, Doctor
Beijing GoBroad Hospital
Outcome results
None listed