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Introduction <p>In China, the prevalence of type&#xa0;2 diabetes mellitus (T2DM) is high, and for those treated with daily basal insulin regimens, suboptimal adherence is common. Once-weekly (QW) basal insulin, such as insulin efsitora alfa (efsitora), may improve treatment adherence and reduce burden. This phase&#xa0;1 study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of QW efsitora versus once-daily (QD) insulin glargine in Chinese patients with T2DM.</p> Methods <p>In this randomized, open-label, active-controlled, multiple-dose study, adults with T2DM on stable basal daily insulin (± non-insulin antihyperglycemic medication) randomized 2:1 to receive QW efsitora or QD glargine for 6&#xa0;weeks. PK parameters were assessed using non-compartmental analysis. PD endpoints included fasting plasma glucose, 7-point self-monitored blood glucose, HbA1c, and lipid profiles. Safety was evaluated by incidence and severity of treatment-emergent adverse events (TEAEs), hypoglycemia, and immunogenicity.</p> Results <p>Thirty-one patients (mean age 59.2&#xa0;years; 58.1% male) were enrolled (efsitora, <i>n</i> = 21; glargine, <i>n</i> = 10). Efsitora exhibited a prolonged elimination half-life (~ 15&#xa0;days), with apparent clearance of 0.0195&#xa0;L/h, and apparent volume of distribution of 10.1&#xa0;L. Both groups showed comparable reductions in fasting glucose and stable daily glucose profiles. No apparent changes in HbA1c were observed. Lipid profiles and C-peptide levels remained stable overall. TEAEs occurred in 81.0% (efsitora) and 80.0% (glargine) of patients, all mild or moderate; no deaths or discontinuations were reported. Hypoglycemic events were mostly asymptomatic and resolved with self-treatment. No treatment-emergent anti-drug antibodies were detected.</p> Conclusion <p>Once-weekly efsitora demonstrated promising PK and PD profiles and glycemic control comparable to once-daily glargine, with a similar safety profile, in Chinese patients with T2DM. These findings support further investigation of efsitora as a once-weekly basal insulin option in this population.</p> Trial Registration <p>ClinicalTrials.gov identifier: NCT05596747.</p>

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Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年7月9日

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  • Hui Liu,
  • Yuxin Fan,
  • Yihui Wang,
  • Yuan Yuan,
  • Jennifer K. Leohr,
  • Ming Liu,
  • Yerong Yu

摘要

Introduction

In China, the prevalence of type 2 diabetes mellitus (T2DM) is high, and for those treated with daily basal insulin regimens, suboptimal adherence is common. Once-weekly (QW) basal insulin, such as insulin efsitora alfa (efsitora), may improve treatment adherence and reduce burden. This phase 1 study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of QW efsitora versus once-daily (QD) insulin glargine in Chinese patients with T2DM.

Methods

In this randomized, open-label, active-controlled, multiple-dose study, adults with T2DM on stable basal daily insulin (± non-insulin antihyperglycemic medication) randomized 2:1 to receive QW efsitora or QD glargine for 6 weeks. PK parameters were assessed using non-compartmental analysis. PD endpoints included fasting plasma glucose, 7-point self-monitored blood glucose, HbA1c, and lipid profiles. Safety was evaluated by incidence and severity of treatment-emergent adverse events (TEAEs), hypoglycemia, and immunogenicity.

Results

Thirty-one patients (mean age 59.2 years; 58.1% male) were enrolled (efsitora, n = 21; glargine, n = 10). Efsitora exhibited a prolonged elimination half-life (~ 15 days), with apparent clearance of 0.0195 L/h, and apparent volume of distribution of 10.1 L. Both groups showed comparable reductions in fasting glucose and stable daily glucose profiles. No apparent changes in HbA1c were observed. Lipid profiles and C-peptide levels remained stable overall. TEAEs occurred in 81.0% (efsitora) and 80.0% (glargine) of patients, all mild or moderate; no deaths or discontinuations were reported. Hypoglycemic events were mostly asymptomatic and resolved with self-treatment. No treatment-emergent anti-drug antibodies were detected.

Conclusion

Once-weekly efsitora demonstrated promising PK and PD profiles and glycemic control comparable to once-daily glargine, with a similar safety profile, in Chinese patients with T2DM. These findings support further investigation of efsitora as a once-weekly basal insulin option in this population.

Trial Registration

ClinicalTrials.gov identifier: NCT05596747.