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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight, Obesity
• Intervention / Treatment: Drug: ZT002 injection; Drug: ZT002 injection matching placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Liu; Phone Number: +86-13911711598; Email: liu.li@qlbiopharm.com

Study Locations

• China
  • Beijing, China, 102200
    • Beijing GoBroad Hospital
    • Contact: Quankun Zhuang, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort1 ZT002 injection; 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.	Drug: ZT002 injection; Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
Experimental: cohort2 ZT002 injection matching placebo; 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.	Drug: ZT002 injection matching placebo; Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Quankun Zhuang, Doctor, Beijing GoBroad Hospital; Principal Investigator: Xuemei Liu, Doctor, Beijing GoBroad Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 18, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): March 24, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: BJQL-ZT002-1008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No