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Starting soon Phase 1

A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants

NCT07916194 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-11-13
Last updated
2026-11-04

Condition(s) studied

Overweight, Obesity

Investigational drug(s) / intervention(s)

Zovaglutide →Zovaglutide →Zovaglutide →

Zovaglutide: All subjects will be treated with a single subcutaneous injection of Zovaglutide

Zovaglutide: All subjects will be treated with a single subcutaneous injection of Zovaglutide

Zovaglutide: All subjects will be treated with a single subcutaneous injection of Zovaglutide.

Study summary

This study is a single-dose, open-label, non-randomized, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with varying degrees of Hepatic Impairment and matched participants with normal hepatic function.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: All participants: * Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Informed Consent Form (ICF). * Body Mass Index (Body mass index (BMI) 18.0 - 32.0 kg/m² (both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants. * Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent. Participants with Hepatic Impairment: • Participants with chronic mild and moderate hepatic impairment, assessed by Child-Pugh scoring Exclusion Criteria: All participants: * History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history. * 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).or any GI disease which impacts gastric emptying * Have a history of severe GI disease within 6 months before screening , or have received GI surgery (appendectomy, cholecystectomy are excepted), or clinically significant gastric emptying disorders. * Medical history of hypoglycemia within 6 months before screening; * eGFR\<60 mL/min/1.73m² Participants with Hepatic Impairment: * Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period; * Have a severe portal shunt or prior portosystemic shunt within 3 months before screening; * Severe ascites and/or pleural effusion requiring paracentesis; * Have other causes of hepatic injury unrelated to hepatic parenchymal disease and/or cholestatic liver disease at screening;. * History of acute liver failure, esophagogastric variceal bleeding within 6 months before screening; * History of Hepatic encephalopathy of Grade 3 or 4. * Have hemoglobin \<70 grams per deciliter (g/L) * Have platelet \<50×10\^9/L * HbA1c ≥ 8.0% or fasting blood glucose ≥ 11.10 mmol/L at screening.

Primary outcome measure(s)

  • Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞) — Start of treatment up to Day 36
  • Maximum Concentration of ZT002 (Cmax) — Start of treatment up to Day 36
  • Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t) — Start of treatment up to Day 36

Trial sites (3)

FacilityCityRegionStatus
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou Zhengzhou Henan
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07916194 on ClinicalTrials.gov ↗ ← All trials in China