Annals of internal medicine · 2026
Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Liu Ming, Cheng Zhifeng, Lu Li, Cai Hanqing, Liu Jingyu, Liu Jinling, Zheng Yueyue, Wang Su, Zhao Jing, Yang Wei, Xie Tian, Li Yue, He Anshun, Rodbard Helena W, Chen Wei
Аннотация
BACKGROUND: Bofanglutide is a novel glucagon-like peptide-1 receptor agonist under development for type 2 diabetes mellitus (T2DM) and overweight and obesity.
OBJECTIVE: To evaluate the efficacy and safety of bofanglutide compared with semaglutide.
DESIGN: Phase 2b, randomized, open-label, active-controlled trial. (ClinicalTrials.gov: NCT06256549).
SETTING: Multicenter (37 sites in China).
PARTICIPANTS: Adults with T2DM who were drug-naive or receiving stable oral antidiabetic drugs (glycated hemoglobin A1c [HbA1c], 7.0% to 11.0%).
INTERVENTION: Participants were randomly assigned 1:1:1:1:1 to 1 of 5 treatment groups: bofanglutide titrated to targets of 12, 18, or 24 mg (biweekly [once every 2 weeks; Q2W]); bofanglutide titrated to 24 mg (once weekly [QW]); or semaglutide titrated to 1 mg QW.
MEASUREMENTS: Change in HbA1c level from baseline to week 24 (primary end point), secondary efficacy end points, and safety.
RESULTS: Overall, 272 participants were enrolled, with a mean age of 50.8 years, HbA1c level of 8.35%, and body mass index of 27.9 kg/m2. At week 24, HbA1c level change from baseline was -1.87% (95% CI, -2.11% to -1.63%), -2.28% (CI, -2.54% to -2.03%), and -1.94% (CI, -2.19% to -1.69%) for bofanglutide 12, 18, 24 mg Q2W, respectively; -2.32% (CI, -2.57% to -2.06%) for bofanglutide 24 mg QW; and -1.60% (CI, -1.85% to -1.35%) for 1 mg of semaglutide QW. Corresponding treatment differences versus semaglutide were -0.27% (CI, -0.61% to -0.08%), -0.68% (CI, -1.04% to -0.33%), -0.34% (CI, -0.70% to 0.02%), and -0.72% (CI, -1.08% to -0.36%), respectively. Gastrointestinal adverse events (GIAEs) (mostly grade 1 or 2 in severity) occurred in 81.8% to 87.3% and 51.9% of participants in the bofanglutide and semaglutide groups, respectively. Hypoglycemia occurred in 0% to 3.8% versus 1.9%, with no severe hypoglycemia.
LIMITATION: Open-label, short duration, only Chinese participants.
CONCLUSION: Meaningful reductions in HbA1c levels were seen with bofanglutide in patients with T2DM; GIAEs were the most common and generally manageable.
PRIMARY FUNDING SOURCE: Gan & Lee Pharmaceuticals.
OBJECTIVE: To evaluate the efficacy and safety of bofanglutide compared with semaglutide.
DESIGN: Phase 2b, randomized, open-label, active-controlled trial. (ClinicalTrials.gov: NCT06256549).
SETTING: Multicenter (37 sites in China).
PARTICIPANTS: Adults with T2DM who were drug-naive or receiving stable oral antidiabetic drugs (glycated hemoglobin A1c [HbA1c], 7.0% to 11.0%).
INTERVENTION: Participants were randomly assigned 1:1:1:1:1 to 1 of 5 treatment groups: bofanglutide titrated to targets of 12, 18, or 24 mg (biweekly [once every 2 weeks; Q2W]); bofanglutide titrated to 24 mg (once weekly [QW]); or semaglutide titrated to 1 mg QW.
MEASUREMENTS: Change in HbA1c level from baseline to week 24 (primary end point), secondary efficacy end points, and safety.
RESULTS: Overall, 272 participants were enrolled, with a mean age of 50.8 years, HbA1c level of 8.35%, and body mass index of 27.9 kg/m2. At week 24, HbA1c level change from baseline was -1.87% (95% CI, -2.11% to -1.63%), -2.28% (CI, -2.54% to -2.03%), and -1.94% (CI, -2.19% to -1.69%) for bofanglutide 12, 18, 24 mg Q2W, respectively; -2.32% (CI, -2.57% to -2.06%) for bofanglutide 24 mg QW; and -1.60% (CI, -1.85% to -1.35%) for 1 mg of semaglutide QW. Corresponding treatment differences versus semaglutide were -0.27% (CI, -0.61% to -0.08%), -0.68% (CI, -1.04% to -0.33%), -0.34% (CI, -0.70% to 0.02%), and -0.72% (CI, -1.08% to -0.36%), respectively. Gastrointestinal adverse events (GIAEs) (mostly grade 1 or 2 in severity) occurred in 81.8% to 87.3% and 51.9% of participants in the bofanglutide and semaglutide groups, respectively. Hypoglycemia occurred in 0% to 3.8% versus 1.9%, with no severe hypoglycemia.
LIMITATION: Open-label, short duration, only Chinese participants.
CONCLUSION: Meaningful reductions in HbA1c levels were seen with bofanglutide in patients with T2DM; GIAEs were the most common and generally manageable.
PRIMARY FUNDING SOURCE: Gan & Lee Pharmaceuticals.