A phase 1b, randomized, open-label study of once-weekly insulin GZR4 in patients with type 2 diabetes mellitus
Authors' conclusion
GZR4 was safe and well tolerated in patients with diabetes in present trial with pharmacokinetic and pharmacodynamic profiles enabling once-weekly dosing.
Study context
- Population
- Adults with T2D on stable daily basal insulin therapy
- Comparison
- Once-weekly GZR4 vs once-daily insulin degludec
- Primary endpoint
- Incidence of AEs, SAEs and hypoglycemia
Methodological detailsphase 1b, open-label, active-controlled, multiple ascending doses, 3 cohorts, randomized 3:1
- Phase 1b
- Open-label
- Active-controlled
- Multiple ascending doses
- 3 cohorts
- Randomized 3:1
Primary result
As reported in the abstract
AEs, SAEs and hypoglycemia
Serious adverse events (SAEs) or severe hypoglycemia observed
0
Further findings
- Mean change in FPG · baseline to week 6 — insulin degludec (IDeg)
- mean −1.12 ± 0.36 mmol/L
- Change in HbA1c · baseline to week 6 — IDeg
- mean −0.13 ± 0.21 %
- Mean change in FPG — GZR4 groups (range across doses)
- −1.77 ± 0.20 to −2.75 ± 0.71 mmol/L
- Change in HbA1c — GZR4 groups (range across doses)
- −0.38 ± 0.64 % to −0.76 ± 0.14 %
GZR4 mean Cmax at steady state (range across GZR4 doses)
- Mean Cmax of GZR4
- 289.0 ± 17.1 to 1,016.0 ± 262.4 ng/mL
GZR4 mean AUC 0-168h at steady state (range across GZR4 doses)
- Mean AUCGZR4, 0-168h
- 34,449.6 ± 2,055.7 to 137,064.2 ± 41,496.5 h.ng/mL
Safety
Adverse events (AEs), SAEs and severe hypoglycemia
- SAEs or severe hypoglycemia
- 0
- Most common treatment-emergent AE: hypoglycemia
Original publication
A phase 1b, randomized, open-label study of once-weekly insulin GZR4 in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. Published 18 December 2025. doi:10.
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