Study S001358

A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate 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

ClinicalTrials.gov record

Registration

Registration: NCT06778967
Acronym: Optimum 2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 1100
Start: 2025-02-13
Primary completion: 2026-12-11
Lead sponsor: Gan & Lee Pharmaceuticals.
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG:GZR18; DRUG:semaglutide
Results posted: FALSE

Registered primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)(%) [Baseline, Week 44]

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