A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

Sponsor
Gan and Lee Pharmaceuticals, USA
Study ID
NCT06256549
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GZR18 — DRUG
    Titrated to low dose or middle or high dose
  • Semaglutide — DRUG
    Titrated to 1.0 mg once a week

Study Details

This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.

Key Dates

Start date
Aug 9, 2023
Status verified
Jan 2024
Primary completion
Jul 20, 2024
Completion
Jul 20, 2024

Study Design

Enrollment
272 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR18
    GZR18 injection s.c.
  • Active Comparator: Semaglutide
    Semaglutide injection s.c.

Primary Outcome Measure

Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks [ Time Frame: 24 weeks ]

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