Overweight, ObesityPhase 1NCT07697846

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

A Phase 1 study testing ZT002 injection in people with Overweight, Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Overweight, Obesity
What is being tested?: ZT002 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteChina
Study dates: 15 Jul 2026to 24 Mar 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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);

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing GoBroad Hospital
Beijing, China, 102200

Other trials in China

About this study

Official 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

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.

Conditions: Overweight, Obesity
Being tested: ZT002 injection, ZT002 injection matching placebo
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZT002 injectionDrug
Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
ZT002 injection matching placeboDrug
Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.

Study groups in NCT07697846
Study group	Role	What they receive
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. Receives: Drug: ZT002 injection
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. Receives: Drug: ZT002 injection matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 141

Secondary outcomes (16)

Effect of ZT002 plasma concentrations on heart rate (HR)
Measure the Effect of ZT002 plasma concentrations on HR
Measured: 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;
Measured: Up to Day 141
Effect of ZT002 plasma concentrations on PR interval
Measure the Effect of ZT002 plasma concentrations on PR interval
Measured: Up to Day 141
Effect of ZT002 plasma concentrations on QRS complex duration
Measure the Effect of ZT002 plasma concentrations on QRS complex duration
Measured: Up to Day 141
Effect of ZT002 plasma concentrations on T wave
Measure the Effect of ZT002 plasma concentrations on T wave
Measured: Up to Day 141
Effect of ZT002 plasma concentrations on U wave
Measure the Effect of ZT002 plasma concentrations on U wave
Measured: Up to Day 141
PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h)
Measured: Up to Day 141
PK parameter analysis of ZT002 for peak concentration (Cmax)
Measured: Up to Day 141
PK parameter analysis of ZT002 for time to peak concentration (Tmax)
Measured: Up to Day 141
Incident of anti-drug antibody against ZT002
Measured: Up to Day 141
Incidence of adverse events (AEs)
Measured: Up to Day 141
Change in body weight (kg)
Measured: Up to Day 141
Change in Body Mass Index (BMI) (kg/m²)
Measured: Up to Day 141
Change in waist circumference (cm)
Measured: Up to Day 141
Change in hip circumference (cm)
Measured: Up to Day 141
Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%)
Measured: Up to Day 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202624 Mar 2027

First posted13 Jul 2026
Study start15 Jul 2026
Primary completion13 Jan 2027 (estimated)
Study completion24 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight, ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07697846
Sponsor's protocol ID: BJQL-ZT002-1008
Status last verified: Oct 2026
First submitted: 29 Jun 2026
Last updated: 21 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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