Safety, pharmacokinetics and pharmacodynamics of HRS ‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial
Authors' conclusion
HRS-7535 exhibited a safety and tolerability profile consistent with other GLP-1RAs and showed PKs suitable for once-daily dosing. These findings support further clinical development of HRS-7535 for type 2 diabetes.
Study context
- Population
- Healthy participants
- Comparison
- HRS-7535 vs placebo
- Primary endpoint
- Safety and tolerability
Methodological detailsphase 1, double-blind, placebo-controlled, single-ascending dose, multiple-ascending dose, food effect
- Phase 1
- Double-blind
- Placebo-controlled
- Single-ascending dose
- Multiple-ascending dose
- Food effect
Primary result
As reported in the abstract
- Nausea and vomiting were the most frequently reported AEs across all three parts
Further findings
Mean reduction in body weight from baseline, MAD part · day 29 HRS-7535 mean 4.38 kg · Placebo mean 0.8 kg
Percentage reduction
PK, single-ascending dose (SAD) part
- Median Tmax across HRS-7535 doses
- 5.98-5.99 hours
- Geometric mean t1/2 across HRS-7535 doses
- 5.28-9.08 hours
PK, multiple-ascending dose (MAD) part · day 28
- Median Tmax with HRS-7535
- 5.98-10.98 hours
- Geometric mean t1/2 with HRS-7535
- 6.48-8.42 hours
- Pharmacokinetics (PKs) approximately dose-proportional
Safety
Adverse events
- Nausea and vomiting were the most frequently reported AEs across all three parts
Original publication
Safety, pharmacokinetics and pharmacodynamics of HRS ‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial. Diabetes Obes Metab. Published 15 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →