Safety, tolerability, pharmacokinetics and pharmacodynamics of GZR4 (GZR4) , a novel once‐weekly basal insulin, in healthy participants: A randomized trial
Authors' conclusion
Once-weekly GZR4 demonstrated good safety and tolerability in healthy participants. It exhibited a dose-dependent and sustained glucose-lowering effect over a full week and demonstrated stronger daily glucose-lowering efficacy than once-daily IDeg under similar molar concentrations. These results support further investigation of once-weekly GZR4 for glycaemic control in patients with diabetes.
Study context
- Population
- Healthy Chinese male adults aged 18–45 years, BMI 19–24 kg/m²42 completed
- Participants
- 43 adults
- Comparison
- Once-weekly GZR4 vs placebo; insulin degludec cohort
- Primary endpoint
- Safety and tolerability of GZR4
Methodological detailssingle-blind, dose-escalation, Phase 1a, Euglycaemic glucose clamps 24-48 h (Day 2) and 144-168 h (Day 7) after GZR4, and 0-24 h (Day 1) after insulin degludec (IDeg)
- Single-blind
- Dose-escalation
- Phase 1a
- Euglycaemic glucose clamps 24-48 h (Day 2) and 144-168 h (Day 7) after GZR4, and 0-24 h (Day 1) after IDeg
Primary result
As reported in the abstract
- Deaths, serious adverse events (SAEs) or discontinuations related to investigational product
- 0
Further findings
PD: AUCGIR (euglycaemic clamp)
AUCGIR,24-48h GZR4 6 nmol/kg 54.91
AUCGIR,144-168h GZR4 6 nmol/kg 37.84
AUCGIR,0-24h IDeg 40.59
— not stated in the abstract
Pharmacokinetics (PK) of GZR4
- PK parameters increased linearly with dose from 1 to 12 nmol/kg; glucose-lowering effect sustained for ≈1 week
Pharmacodynamics (PD): AUCGIR (euglycaemic clamp)
- Comparable AUCGIR; GZR4 potency may be ≈3.2-times greater than IDeg weekly
Safety
Adverse events
- Deaths, SAEs or discontinuations related to investigational product
- 0
- Hypoglycaemia (most common TEAE) only with GZR4 12 nmol/kg
- All treatment-emergent adverse events (TEAEs) mild to moderate
Original publication
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