A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single-dose of Zovaglutide (ZT002 Injection) in Participants With Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function

Registration

Registration

NCT07443059

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

RECRUITING

Enrollment

40

Start

2026-04-13

Primary completion

2026-12-03

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Conditions

Overweight , Obesity

Interventions

DRUG:Zovaglutide

Results posted

FALSE

Registered primary outcomes

• Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t). [Start of Treatment up to Day 50]
• Maximum Concentration of ZT002 (Cmax) [Start of Treatment up to Day 50]
• Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞) [Start of Treatment up to Day 50]
• Time to maximum concentration (Tmax) [From baseline to Day 50]
• Apparent terminal half-life (t1/2) [From baseline to Day 50]
• Apparent clearance (CL/F) [From baseline to Day 50]
• Incidence and severity of adverse events [Screening period up to Day 50]