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
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.