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

Korábbi kezelés

• 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;

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• 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;

• 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