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NCT07916194Not yet recruitingPhase 1

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

A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single Dose of Zovaglutide (ZT002 Injection) in Participants With Varying Degrees of Hepatic Impairment and Matched Participants With Normal Hepatic Function

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
First submitted
29 Oct 2026
Start date
13 Nov 2026
Primary completion date
19 Jun 2027
Lead sponsor
Beijing QL Biopharmaceutical Co.,Ltd
Diseases
Obesity
NCT number
NCT07916194

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 24
  • From 13 Nov 2026 to the primary completion date, 19 Jun 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • Have a severe portal shunt or prior portosystemic shunt within 3 months before screening;
  • History of acute liver failure, esophagogastric variceal bleeding within 6 months before screening;

Other illness

  • History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
  • Have other causes of hepatic injury unrelated to hepatic parenchymal disease and/or cholestatic liver disease at screening;.
  • History of Hepatic encephalopathy of Grade 3 or 4.

Lab values

  • eGFR\<60 mL/min/1.73m²
    • Participants with Hepatic Impairment:
  • 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.

Other

  • All participants:
  • Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;
  • Severe ascites and/or pleural effusion requiring paracentesis;

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
The Second Affiliated Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.