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

NCT07697846 | Not Yet Recruiting Phase 1

• 1 other identifier: BJQL-ZT002-1008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight, Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Effect of ZT002 plasma concentrations on heart rate (HR)

  Up to Day 141

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

  Up to Day 141

• Effect of ZT002 plasma concentrations on PR interval

  Up to Day 141

• Effect of ZT002 plasma concentrations on QRS complex duration

  Up to Day 141

• Effect of ZT002 plasma concentrations on T wave

  Up to Day 141

Study Arms (2)

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.

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.

Drug: ZT002 injection matching placebo

Interventions

ZT002 injection DRUG

Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.

cohort1 ZT002 injection

ZT002 injection matching placebo DRUG

Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.

cohort2 ZT002 injection matching placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, 102200, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Quankun Zhuang, Doctor

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

• Xuemei Liu, Doctor

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Liu

CONTACT

+86-13911711598; liu.li@qlbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 13, 2026
• Study Start: July 18, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): March 24, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-06

Locations

CN (1)