Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT07387003
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Type 2 Diabetes (T2DM)

Eligibility Criteria

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

Interventions

  • GZR101-80 — DRUG
    Administered SC
  • GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) — DRUG
    Administered SC

Study Details

This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.

Key Dates

Start date
Apr 10, 2026
Status verified
Sep 2025
Primary completion
Feb 11, 2027
Completion
Sep 23, 2027

Study Design

Enrollment
345 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GZR101-80
  • Active Comparator: GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30)

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. [ Time Frame: Baseline , 16 weeks ]

Central Contacts

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