A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

NCT06778967 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effects of the experimental drug GZR18 Injection in adults with Type 2 Diabetes Mellitus.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 1,100 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-02 · est. completion 2026-12

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06778967 ↗

Description as written by the study sponsor.

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

Treatments tested

GZR18 Drug

Administered SC
semaglutide Drug

Administered SC

Main thing measured	Change from Baseline in Hemoglobin A1c (HbA1c)(%)
Sponsor	Gan & Lee Pharmaceuticals.
Conditions studied	Type 2 Diabetes Mellitus (T2DM)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06778967 ↗