Pharmacokinetics and safety of HR17031 , a fixed‐ratio of INS068 /Noiiglutide combination, in Chinese patients with hepatic impairment
Authors' conclusion
HR17031 demonstrated PK profiles of INS068 and Noiiglutide comparable between subjects with mild or moderate hepatic impairment and those with normal hepatic function, with modest reductions in moderate impairment. The treatment was well tolerated with a favourable safety profile, and no significant differences in C-peptide concentrations were observed across groups.
Study context
- Population
- Chinese subjects with mild or moderate hepatic impairment or normal hepatic function receiving a single SC injection of HR17,031 (10 U/0.024 mg; fixed-ratio INS068/Noiiglutide)
- Participants
- 24 subjects
- Comparison
- Mild or moderate hepatic impairment vs normal hepatic function
- Mildn = 8
- Moderaten = 8
- Normaln = 8reference
- Outcome
- PK of INS068 and Noiiglutide
Methodological detailsopen-label, single-dose, nonrandomised, parallel-design
- Open-label
- Single-dose
- Nonrandomised
- Parallel-design
Main finding
As reported in the abstract
Each group vs normalEstimate (CI)
Moderate
INS068 AUC0-∞ GMR 0.814(0.703–0.944)
Moderate
Noiiglutide AUC0-∞ GMR 0.713(0.574–0.886)
Further findings
Unbound fractions and C-peptide concentrations
- Unbound fractions of both components and C-peptide showed no significant differences across groups
Safety
- Serious adverse events
- 0
- HR17031 well tolerated
Original publication
Pharmacokinetics and safety of HR17031 , a fixed‐ratio of INS068 /Noiiglutide combination, in Chinese patients with hepatic impairment. Diabetes Obes Metab. Published 12 January 2026. doi:10.
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