Pharmacokinetics and Food Effect of HDM1002, a Novel Oral Small-Molecule GLP-1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study.
Diabetes Obes MetabJun 17, 2026 (epub)
Chunqi Huang, Yiyang Ying, Yi Wu et al.
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In 30 seconds
This randomized controlled trial evaluated the pharmacokinetics and food effects of HDM1002, a novel GLP-1 receptor agonist, in 33 healthy Chinese volunteers. The study found that the two tablet strengths (100 mg and 200 mg) were bioequivalent under fasting conditions, with a notable reduction in C max when the 200 mg tablet was taken after a high-fat meal, but no significant impact on overall exposure (AUC).
Key findings
- The 90% confidence intervals for bioequivalence of C max, AUC 0-t, and AUC 0-∞ were within the 80.00%-125.00% range.
- C max for the 200-mg tablet after a high-fat meal was 87.53% (76.88%, 99.66%) compared to fasting.
- AUC 0-t and AUC 0-∞ for the 200-mg tablet after a high-fat meal were 105.90% and 106.01%, respectively.
Why it matters
Understanding the pharmacokinetics and food effects of new medications is crucial for optimizing dosing regimens and ensuring efficacy. This study provides important insights into how food intake can influence the absorption of HDM1002, which may impact clinical use.