Safety, pharmacokinetics and pharmacodynamics of multiple‐dose noiiglutide ( SHR20004 ), a novel GLP ‐1 receptor agonist, in Chinese obese subjects without diabetes mellitus
Authors' conclusion
Daily administration of noiiglutide using a titration method was well tolerated by Chinese obese participants without DM and showed potential therapeutic effect for weight loss.
Study context
- Population
- Chinese adults with obesity (body mass index (BMI) ≥28 kg/m²) without diabetes mellitus (DM)10 per dose group (8 noiiglutide, 2 placebo)
- Comparison
- Daily noiiglutide titrated to 0.18, 0.24, 0.30 or 0.36 mg/day vs placebo
- 0.18 mgn = 8
- 0.24 mgn = 8
- 0.30 mgn = 8
- 0.36 mgn = 8
- Primary endpoint
- Safety, pharmacokinetics and pharmacodynamics
Methodological detailsphase 1, double-blind, placebo-controlled, titration, multiple-dose
- Phase 1
- Double-blind
- Placebo-controlled
- Titration
- Multiple-dose
Primary result
As reported in the abstract
Safety, pharmacokinetics
Mean elimination half-life (t1/2) at steady state
9.90 to 11.8 h
Further findings
| Outcome | Values |
|---|---|
| Mean weight change from baseline · end of treatment | Placebo mean −1.89 kg · 0.18 mg mean −3.26 kg · 0.24 mg mean −5.45 kg · 0.30 mg mean −4.35 kg · 0.36 mg mean −7.46 kg |
Mean weight change from baseline · end of treatment
- Weight and BMI reductions in each noiiglutide group greater than placebo, increasing with extended administration duration
Safety
Adverse events
- Serious AEs
- 0
- AEs leading to withdrawal
- 0
- Most treatment-emergent AEs mild to moderate
Original publication
Safety, pharmacokinetics and pharmacodynamics of multiple‐dose noiiglutide ( SHR20004 ), a novel GLP ‐1 receptor agonist, in Chinese obese subjects without diabetes mellitus. Diabetes Obes Metab. Published 1 December 2024. doi:10.
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