Active not recruitingPhase 1

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

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Asset

Zovaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 24-35

Primary endpoint

•Change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07697846

Org study IDBJQL-ZT002-1008

Timeline

Milestones

Study first posted2026-07-13actual

Study start2026-07-15actual

Last update posted2026-10-21actual

Primary completion2027-01-13estimated

Study completion2027-03-24estimated

Assets

Investigational agents

Zovaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight (kg)

Time frame:Up to Day 141

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to Day 141

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference (cm)

Time frame:Up to Day 141

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Effect of ZT002 plasma concentrations on heart rate (HR)

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to Day 141

change from baseline, improvement

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

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

Time frame:Up to Day 141

descriptive

Secondary/protocol endpoint

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

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

Effect of ZT002 plasma concentrations on PR interval

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

Effect of ZT002 plasma concentrations on QRS complex duration

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

Effect of ZT002 plasma concentrations on T wave

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

Effect of ZT002 plasma concentrations on U wave

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to Day 141

descriptive

Secondary/protocol endpoint

PK parameter analysis of ZT002 for peak concentration (Cmax)

Time frame:Up to Day 141

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to Day 141

time to event, event

Secondary/protocol endpoint

Incident of anti-drug antibody against ZT002

Time frame:Up to Day 141

descriptive

Secondary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:Up to Day 141

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in hip circumference (cm)

Time frame:Up to Day 141

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.