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NCT07916194
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Conditions: Overweight, Obesity
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
Location: The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
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 Criteria
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\
Source: ClinicalTrials.gov (NCT07916194). StuddyBuddy aggregates publicly available trial information.