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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort1 ZT002 injection | Experimental | Participants will receive 8 study interventions. The study interventions will be administered during treatment periods starting on Days 1, 15, 29, 43, 57, 71, 85 and 99. |
|
| cohort2 ZT002 injection matching placebo | Experimental | Participants will receive 8 matching placebo interventions. The interventions will be administered during treatment periods starting on Days 1, 15, 29, 43, 57, 71, 85 and 99. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZT002 injection | Drug | Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change to baseline- and placebo-corrected QTc interval (ΔΔQTc) | Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling. | Up to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of ZT002 plasma concentrations on heart rate (HR) | Measure the Effect of ZT002 plasma concentrations on HR | Up to Day 141 |
| Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Liu | Contact | +86-13911711598 | liu.li@qlbiopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Quankun Zhuang, Doctor | Beijing GoBroad Hospital | Principal Investigator |
| Xuemei Liu, Doctor | Beijing GoBroad Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | 102200 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ZT002 injection matching placebo | Drug | Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks. |
|
Measure the Effect of ZT002 plasma concentrations on QTcF;
| Up to Day 141 |
| Effect of ZT002 plasma concentrations on PR interval | Measure the Effect of ZT002 plasma concentrations on PR interval | Up to Day 141 |
| Effect of ZT002 plasma concentrations on QRS complex duration | Measure the Effect of ZT002 plasma concentrations on QRS complex duration | Up to Day 141 |
| Effect of ZT002 plasma concentrations on T wave | Measure the Effect of ZT002 plasma concentrations on T wave | Up to Day 141 |
| Effect of ZT002 plasma concentrations on U wave | Measure the Effect of ZT002 plasma concentrations on U wave | Up to Day 141 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |