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A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT06256523 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-23

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.

Conditions

Interventions

DRUG

GZR18

0.5mg-13mg

OTHER

Placebo

administered the same volume as GZR18

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

  • Liyuan Zhao, Ph.D · Gan & Lee Pharmaceuticals.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2023-09-28
Completion
2023-09-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06256523 on ClinicalTrials.gov