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Impact of PCSK9 Inhibitor Recaticimab on Hyperlipidemia and Plasma Glucose: A Randomized, Double-Blind,

Ye Hu1, Chen Chen1, Xiao Hui He1

  • 1Department of Clinical Pharmacology, Beijing Luhe Hospital, Capital Medical University, Beijing 101199, China.

Biomedical and Environmental Sciences : BES
|November 6, 2025
PubMed
Abstract

Insights

Recaticimab (SHR-1209) did not adversely affect glucose metabolism in Chinese patients with hyperlipidemia. This study indicates the drug is safe for individuals with or without diabetes, showing no negative glycemic impacts.

Area of Science:

  • Cardiovascular Medicine
  • Endocrinology
  • Pharmacology

Background:

  • Recaticimab (SHR-1209) is known to reduce low-density lipoprotein cholesterol.
  • The impact of Recaticimab on glucose metabolism is not well-established.
  • Evaluating glycemic effects is crucial for patient safety.

Purpose of the Study:

  • To assess the effect of Recaticimab on glycemic parameters.
  • To investigate its safety in a Chinese population with hyperlipidemia.
  • To determine if Recaticimab impacts fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c).

Main Methods:

  • A 24-week randomized controlled trial comparing Recaticimab to placebo in 110 hyperlipidemia patients.
  • Fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) were measured longitudinally.
  • Repeated-measures mixed-effects models analyzed the association between Recaticimab and glycemic levels.

Main Results:

  • In participants with normal glucose metabolism, HbA1c levels significantly decreased (P=0.036).
  • In participants with abnormal glucose metabolism, FPG levels showed a significant time effect (P=0.016).
  • No significant group × time interactions were found for FPG or HbA1c, indicating no differential effect based on baseline glucose status.

Conclusions:

  • Recaticimab demonstrated no adverse glycemic effects in patients with normal or abnormal glucose metabolism.
  • The findings support the safety of Recaticimab for individuals with or without diabetes.
  • Recaticimab can be safely used in hyperlipidemia patients regardless of their glucose metabolism status.
Keywords:
Fasting plasma glucoseGlycemiaHbA1cHyperlipidemiaPCSK9 inhibitor

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