A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

Sponsor
Gan and Lee Pharmaceuticals, USA
Study ID
NCT06553248
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • GZR4 — DRUG
    Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks
  • Insulin Degludec — DRUG
    Administered once daily subcutaneously (s.c., under the skin) for 6 weeks

Study Details

This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes

Key Dates

Start date
Mar 22, 2023
Status verified
Aug 2024
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023

Study Design

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

Arms

  • Experimental: GZR4
    s.c., once weekly
  • Active Comparator: Insulin Degludec
    s.c., once daily

Primary Outcome Measure

Incidence of TEAE [ Time Frame: Baseline to Week 6 ]

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