Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants

Hao, X; Liu, L; Li, P; Lei, C; Tong, Y; Dong, J; Liu, X; Cheng, X; Zhao, J; Min, X; Zhang, Y; Chen, W

doi:10.1016/j.diabres.2026.113437

Type 2 & other diabetes

Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants

Diabetes Res Clin PractPublished 13 Jul 2026Phase 1 pharmacokinetic and pharmacodynamic study

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Authors' conclusion

Oral bofanglutide was safe and well tolerated.

Study context

Population: Healthy Chinese participantsPart A 44, Part B 48

Comparison: Oral bofanglutide (with SNAC) vs SC bofanglutide injection; 30- vs 60-min post-dose fast
Outcome: Safety, relative bioavailability and pharmacokinetics (PK)

Methodological detailssingle and multiple doses, two parts

Single and multiple doses
Two parts

Main finding

As reported in the abstract

Part A single-dose relative bioavailability, 30/60 mg

0.56%

Part A single-dose relative bioavailability, 90 mg

1.31%

Part A Cmax increased dose-dependently (ng/mL)

40.95 to 254.47

Part A AUC0-t increased dose-dependently (h·ng/mL)

3980.76 to 28180.67

Further findings

Part B: apparent relative bioavailability by post-dose fast · based on repeated-dose exposure with accumulation

60-minute fast9.22%

30-minute fast4.88%

Part B: apparent relative bioavailability by post-dose fast

A 60-min post-dose fast produced approximately twice the exposure of a 30-min fast

Safety

Serious adverse events (AEs) or severe hypoglycemia: 0
Most treatment-emergent AEs related to oral bofanglutide were grade 1 gastrointestinal AEs

Reference

Authors: Hao X, Liu L, Li P, Lei C, Tong Y, Dong J, et al.
All 12 authors
Hao X, Liu L, Li P, Lei C, Tong Y, Dong J, Liu X, Cheng X, Zhao J, Min X, Zhang Y, Chen W
Journal: Diabetes Research and Clinical Practice
Published: 13 Jul 2026
DOI: 10.1016/j.diabres.2026.113437
PubMed: 42442555

Topic: Type 2 & other diabetes

Group definitions

30 mg: single dose of oral bofanglutide 30 mg (Part A)
60 mg: single dose of oral bofanglutide 60 mg (Part A)
90 mg: single dose of oral bofanglutide 90 mg (Part A)
Subcutaneous bofanglutide injection: single dose of SC bofanglutide 0.6 mg (Part A)
30-minute fast: once-daily oral bofanglutide for 14 days (30 mg then 60 mg) with a 30-min post-dose fast (Part B)
60-minute fast: once-daily oral bofanglutide for 14 days (30 mg then 60 mg) with a 60-min post-dose fast (Part B)

Original publication

Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants. Diabetes Res Clin Pract. Published 13 July 2026. doi:10.1016/j.diabres.2026.113437

Read the original article ↗

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