The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects
Authors' conclusion
GZR18 demonstrates good tolerability in healthy American and Chinese subjects. No ethnic differences were observed between healthy American and Chinese subjects. The safety, PK and PD profiles of GZR18 support its further clinical evaluation for glycaemic and body weight control.
Study context
- Population
- Healthy American (male; cohorts US-1–3) and Chinese (male and female; cohorts CN-1–6) adults of similar age
- Comparison
- Once-weekly subcutaneous GZR18 vs placebo
- Primary endpoint
- Safety and tolerability of GZR18
Methodological detailsphase 1, double-blind, placebo-controlled, sequential, dose-escalation, US and Chinese studies, Population pharmacokinetics (PK) analysis assessed ethnic PK differences between American and Chinese adults
- Phase 1
- Double-blind
- Placebo-controlled
- Sequential
- Dose-escalation
- US and Chinese studies
- Population PK analysis assessed ethnic PK differences between American and Chinese adults
Primary result
As reported in the abstract
- No deaths, serious adverse events or hypoglycaemia reported
- Decreased appetite and nausea most frequent TEAEs, observed in Chinese study, mild in severity
- Safety profile generally consistent with same drug class
Further findings
PK exposure: American vs Chinese
- Exposure comparable; geometric mean ratio for AUC0-t and Cmax close to 1
- Dose-dependent increase in AUC0-t and Cmax in both populations
Tmax
- Median Tmax, American subjects
- 72 to 96 h
- Mean Tmax, Chinese subjects
- 60 to 72 h
Half-life
- Half-life in American and Chinese subjects
- ≈7 days
Body weight reduction, Chinese cohorts CN-3-6 · Day 15
- Body weight change
- −1.25 to −1.86 kg
- Body weight change (%)
- −1.88% to −3.11%
Safety
- Deaths, serious adverse events or hypoglycaemia
- 0
- Decreased appetite and nausea most frequent TEAEs (Chinese study), mild
Original publication
The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. Published 3 March 2025. doi:10.
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