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

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT06778967
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GZR18 — DRUG
    Administered SC
  • semaglutide — DRUG
    Administered SC

Study Details

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

Key Dates

Start date
Feb 13, 2025
Status verified
Oct 2025
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR18 Dose 1
    Participants will receive GZR18 subcutaneously (SC).
  • Experimental: GZR18 Dose 2
    Participants will receive GZR18 subcutaneously (SC).
  • Active Comparator: semaglutide
    Participants will receive semaglutide subcutaneously (SC).

Primary Outcome Measure

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

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