Efficacy and safety of Efsubaglutide Alfa in "overrun" patients in the SUPER2 trial: A post-hoc analysis for comprehensive evaluation
Abstract
Aims: Efsubaglutide Alfa is a novel, long-acting, once-weekly GLP-1 receptor agonist. In the pivotal phase 2b/3 SUPER2 trial, Efsubaglutide Alfa 3 mg plus metformin showed significant efficacy and favourable safety in patients with type 2 diabetes (T2D) inadequately controlled on metformin. This post-hoc analysis evaluated the 1 mg dose.
Materials and methods: In phase 2b, patients with T2D on metformin were randomized (1:1:1) to once-weekly Efsubaglutide Alfa 1 mg, 3 mg, or placebo for 12 weeks. After interim analysis, 3 mg was selected as the phase 3 dose. However, 155 patients already randomized (the "overrun" cohort) completed 24 weeks of double-blind treatment with 1 mg, then entered 28 weeks of open-label 3 mg and 4 weeks of follow-up. This analysis focused on the 1 mg cohort. The primary endpoint was change in HbA1c at week 24; secondary endpoints included fasting plasma glucose (FPG), body weight, HbA1c <7.0%, and subgroup analyses.
Results: At week 24, HbA1c decreased by -1.69% (95% CI -1.91 to -1.47) with Efsubaglutide Alfa 1 mg versus -0.74% (-0.96 to -0.52) with placebo, a placebo-corrected difference of -0.95% (95% CI -1.25 to -0.65; p < 0.0001). FPG decreased by -2.09 mmol/L versus -0.50 mmol/L with placebo (difference - 1.59 mmol/L; p < 0.001). Body weight reduction was modest and not significant (-2.8% vs. -1.3%; LSM -0.72 kg; p = 0.137). HbA1c <7.0% was achieved by 56.3% versus 11.1% with placebo (p < 0.0001; odds ratio 8.3). Gastrointestinal adverse events…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 155 participants or records.
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