MedTrace Logo

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection

NCT07128888 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-12

No results posted yet for this study

Summary

This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets.

A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender.

The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)

Conditions

  • Obesity or Overweight

Interventions

DRUG

GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets

GZR18 injection: 3 mg-36 mg，16 weeks; Warfarin Sodium Tablets:2.5mg，twice; Rosuvastatin Calcium Tablets：10mg，twice; Digoxin Tablets:0.25mg，twice

Sponsors & Collaborators

  • Gan & Lee Pharmaceuticals.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-07-05
Completion
2026-07-05

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128888 on ClinicalTrials.gov