First‐in‐human study of HDM1002 , a GLP ‐1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers
Authors' conclusion
HDM1002 was safe and well tolerated at 10-600 mg. HDM1002 showed linear pharmacokinetics, and a standardized high-fat meal did not impact systemic exposure. These results provide preliminary evidence supporting further clinical development of HDM1002 in individuals with type 2 diabetes.
Study context
- Population
- Healthy participants aged 18 to 55 years with body mass index (BMI) 19.0 ≈32.0 kg/m²all completed
- Participants
- 79 participants
- Comparison
- Single oral escalating doses of HDM1002 vs placebo; HDM1002 fasted vs fed
- Primary endpoint
- Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of HDM1002
Methodological detailsfirst-in-human, double-blind, placebo-controlled, 2-part, single ascending dose, food-effect crossover
- First-in-human
- Double-blind
- Placebo-controlled
- 2-part
- Single ascending dose
- Food-effect crossover
Primary result
As reported in the abstract
Safety, tolerability, PK and PD
Geometric mean t1/2z range
4.99 to 7.10 h
Safety
Adverse events
- Most common adverse events (AEs) were nausea, diarrhoea, vomiting and decreased appetite, increasing in a dose-dependent manner
- No serious AEs were reported
Original publication
First‐in‐human study of HDM1002 , a GLP ‐1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers. Diabetes Obes Metab. Published 15 July 2025. doi:10.
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