- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07697846
A Study to Investigate the Effects of Zovaglutide (ZT002 Injection) on QTc Interval in Healthy Adults
6. juli 2026 oppdatert av: Beijing QL Biopharmaceutical Co.,Ltd
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Li Liu
- Telefonnummer: +86-13911711598
- E-post: liu.li@qlbiopharm.com
Studiesteder
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Beijing, Kina, 102200
- Beijing GoBroad Hospital
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Ta kontakt med:
- Quankun Zhuang, Master
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Subjects will receive subcutaneous injections of Zovaglutide (ZT002 Injection) once every two weeks.
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Eksperimentell: 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.
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Subjects will receive subcutaneous injections of ZT002 injection matching placebo once every two weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change to baseline- and placebo-corrected QTc interval (ΔΔQTc)
Tidsramme: Up to Day 141
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Effect of ZT002 plasma concentrations on the ΔΔQTc interval using linear mixed effect exposure-response modeling.
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Up to Day 141
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Effect of ZT002 plasma concentrations on heart rate (HR)
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on HR
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Up to Day 141
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Effect of ZT002 plasma concentrations on QT interval corrected using Fridericia's formula (QTcF)
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on QTcF;
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Up to Day 141
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Effect of ZT002 plasma concentrations on PR interval
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on PR interval
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Up to Day 141
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Effect of ZT002 plasma concentrations on QRS complex duration
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on QRS complex duration
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Up to Day 141
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Effect of ZT002 plasma concentrations on T wave
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on T wave
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Up to Day 141
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Effect of ZT002 plasma concentrations on U wave
Tidsramme: Up to Day 141
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Measure the Effect of ZT002 plasma concentrations on U wave
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Up to Day 141
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PK parameter analysis of ZT002 for area under cure from time zero to 72 hours (AUC0-72h)
Tidsramme: Up to Day 141
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Up to Day 141
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PK parameter analysis of ZT002 for peak concentration (Cmax)
Tidsramme: Up to Day 141
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Up to Day 141
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PK parameter analysis of ZT002 for time to peak concentration (Tmax)
Tidsramme: Up to Day 141
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Up to Day 141
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Incident of anti-drug antibody against ZT002
Tidsramme: Up to Day 141
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Up to Day 141
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Incidence of adverse events (AEs)
Tidsramme: Up to Day 141
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Up to Day 141
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Change in body weight (kg)
Tidsramme: Up to Day 141
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Up to Day 141
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Change in Body Mass Index (BMI) (kg/m²)
Tidsramme: Up to Day 141
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Up to Day 141
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Change in waist circumference (cm)
Tidsramme: Up to Day 141
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Up to Day 141
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Change in hip circumference (cm)
Tidsramme: Up to Day 141
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Up to Day 141
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Change in serum lipid concentrations (high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, triglycerides) (%)
Tidsramme: Up to Day 141
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Up to Day 141
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Quankun Zhuang, Doctor, Beijing GoBroad Hospital
- Hovedetterforsker: Xuemei Liu, Doctor, Beijing GoBroad Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
18. juli 2026
Primær fullføring (Antatt)
13. januar 2027
Studiet fullført (Antatt)
24. mars 2027
Datoer for studieregistrering
Først innsendt
29. juni 2026
Først innsendt som oppfylte QC-kriteriene
6. juli 2026
Først lagt ut (Faktiske)
13. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BJQL-ZT002-1008
Legemiddel- og utstyrsinformasjon, studiedokumenter
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