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Introduction <p>Efsubaglutide alfa is a novel, long-acting GLP-1RA, which imparts human homology, molecular flexibility and enhanced GLP-1 receptor-specific binding. This drug-free, observational follow-up evaluated remission and durability of glycemic control in drug-naïve T2D participants who had completed 52&#xa0;weeks of once-weekly efsubaglutide alfa in the SUPER-1 randomized trial.</p> Methods <p>Adults who completed SUPER-1 with HbA1c ≤ 7.0% discontinued all glucose-lowering therapy and entered a 52-week, medication-free observation. The primary endpoint was diabetes remission, defined as HbA1c &lt; 6.5% (American Diabetes Association criteria, ADA 2021) measured ≥ 3&#xa0;months after the last efsubaglutide dose. Kaplan-Meier (KM) analysis was employed to estimate the probability of maintaining HbA1c &lt; 7% over 12&#xa0;months post-treatment. Continuous glucose monitoring (CGM) assessed changes in time in range (TIR). Factors contributing to diabetes remission were analyzed using logistic regression and subgroup KM analyses.</p> Results <p>Twenty-nine participants were enrolled; at 3&#xa0;months post-discontinuation, the diabetes remission rate was 60% (12/20). The probabilities of maintaining HbA1c &lt; 7% at 6- and 12-month post-treatment were 58.1% (17/29; 95% CI 39.0–73.1%) and 41.4% (12/29; 95% CI 24.0–58.0%), respectively. Efsubaglutide alfa treatment during the 52-week period significantly improved TIR (baseline: 46.4%; 52 week: 89.1%, <i>p</i> &lt; 0.001). TIR levels off therapy were 70.1% at 3&#xa0;months, 68.1% at 6&#xa0;months and 64.1% at 12&#xa0;months. Patients who achieved remission had relatively lower baseline HbA1c and higher body mass index (BMI) values before treatment, demonstrating significantly greater reductions in waist circumference (−&#xa0;3.3&#xa0;cm) and postprandial glucose (PPG) levels compared to those who did not remit. Post-treatment HbA1c levels and improvements in homeostasis model assessment of β-cell (HOMA-β) scores were strongly associated with a higher probability of remission (<i>p</i> = 0.03 and 0.05, respectively). Body weight remained stable throughout the 12-month drug-free observation without rebound.</p> Conclusions <p>Efsubaglutide alfa demonstrated efficacy in achieving stable glycemic control and drug-free diabetes remission. Enhanced β-cell function emerged as a key factor contributing to long-term remission.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT06605287.</p>

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Diabetes Remission in Drug-Naïve Patients with Type 2 Diabetes After Efsubaglutide Alfa Treatment

  • 期刊论文

  • 发表日期：

    2026年1月7日

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  • Rui Sun,
  • Kun Wang,
  • Guoyue Yuan,
  • Bimin Shi,
  • Xueying Wang,
  • Anna Shao,
  • Yulong Xu,
  • Qinghua Wang,
  • Jianhua Ma

摘要

Introduction

Efsubaglutide alfa is a novel, long-acting GLP-1RA, which imparts human homology, molecular flexibility and enhanced GLP-1 receptor-specific binding. This drug-free, observational follow-up evaluated remission and durability of glycemic control in drug-naïve T2D participants who had completed 52 weeks of once-weekly efsubaglutide alfa in the SUPER-1 randomized trial.

Methods

Adults who completed SUPER-1 with HbA1c ≤ 7.0% discontinued all glucose-lowering therapy and entered a 52-week, medication-free observation. The primary endpoint was diabetes remission, defined as HbA1c < 6.5% (American Diabetes Association criteria, ADA 2021) measured ≥ 3 months after the last efsubaglutide dose. Kaplan-Meier (KM) analysis was employed to estimate the probability of maintaining HbA1c < 7% over 12 months post-treatment. Continuous glucose monitoring (CGM) assessed changes in time in range (TIR). Factors contributing to diabetes remission were analyzed using logistic regression and subgroup KM analyses.

Results

Twenty-nine participants were enrolled; at 3 months post-discontinuation, the diabetes remission rate was 60% (12/20). The probabilities of maintaining HbA1c < 7% at 6- and 12-month post-treatment were 58.1% (17/29; 95% CI 39.0–73.1%) and 41.4% (12/29; 95% CI 24.0–58.0%), respectively. Efsubaglutide alfa treatment during the 52-week period significantly improved TIR (baseline: 46.4%; 52 week: 89.1%, p < 0.001). TIR levels off therapy were 70.1% at 3 months, 68.1% at 6 months and 64.1% at 12 months. Patients who achieved remission had relatively lower baseline HbA1c and higher body mass index (BMI) values before treatment, demonstrating significantly greater reductions in waist circumference (− 3.3 cm) and postprandial glucose (PPG) levels compared to those who did not remit. Post-treatment HbA1c levels and improvements in homeostasis model assessment of β-cell (HOMA-β) scores were strongly associated with a higher probability of remission (p = 0.03 and 0.05, respectively). Body weight remained stable throughout the 12-month drug-free observation without rebound.

Conclusions

Efsubaglutide alfa demonstrated efficacy in achieving stable glycemic control and drug-free diabetes remission. Enhanced β-cell function emerged as a key factor contributing to long-term remission.

Trial Registration

ClinicalTrials.gov identifier, NCT06605287.