recaticimab (SHR-1209) / Jiangsu Hengrui Pharma - LARVOL DELTA

Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2x2 Factorial, Randomized, Parallel-Group, Multicenter Trial (clinicaltrials.gov) - P4 | N=440 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital | Initiation date: May 2026 ➔ Sep 2026

Trial initiation date • Atherosclerosis • Cardiovascular • Cognitive Disorders • Giant Cell Arteritis

EAST-LDL: Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion (clinicaltrials.gov) - P3 | N=978 | Recruiting | Sponsor: Shanghai East Hospital | N=652 ➔ 978 | Trial completion date: Jan 2029 ➔ Jun 2027 | Trial primary completion date: Jun 2028 ➔ Mar 2027

Enrollment change • Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Efficacy and safety of recaticimab in lowering atherogenic lipids in patients with and without coronary artery disease: a patient-level pooled analysis (ESC 2026) - "Recaticimab demonstrated significant lipid-lowering efficacy, with high rates of guideline-recommended target attainment for atherogenic lipids, and a favourable safety profile in patients with dyslipidaemia, regardless of CAD status. These findings support its use in both CAD and non-CAD patients."

Retrospective data • Cardiovascular • Coronary Artery Disease • Dyslipidemia • APOB

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2025 ➔ Nov 2025

Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders

Comparative efficacy of recaticimab dosing regimens in hypercholesterolemia: a network meta-analysis of randomized controlled trials (ESC 2026) - No abstract available

Retrospective data • Cardiovascular • Dyslipidemia

Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed (clinicaltrials.gov) - P4 | N=29 | Not yet recruiting | Sponsor: Hunan Cancer Hospital

New P4 trial • Dyslipidemia • Lung Cancer • Metabolic Disorders • Mixed Hyperlipidemia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Recaticimab: The First Fc-Engineered PCSK9 Monoclonal Antibody for More Long-Lasting Effect in Lipid Lowering. (PubMed, Drugs) - "However, whether these pharmacological advantages translate into improved cardiovascular outcomes remains to be established, particularly given that current clinical evidence is largely derived from studies conducted in Chinese populations, and thus requires further validation in broader populations. Future studies should evaluate its impact on real-world adherence, cardiovascular outcomes, and cost effectiveness."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia

Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2×2 Randomized Controlled Trial (clinicaltrials.gov) - P4 | N=420 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Cognitive Disorders • Giant Cell Arteritis

Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

REcaticimab for Vascular Efficacy in ReverSing coronary athErosclerotic Plaques: A Multicenter, Prospective, Open-Label, Pragmatic Randomized Controlled Trial (ChiCTR) - P4 | N=1482 | Sponsor: The second affiliated hospital of Zhejiang University school of medicine; The second affiliated hospital of Zhejiang University school of medicine

New P4 trial • Atherosclerosis • Cardiovascular • APOB

LIPID-LOWERING EFFICACY AND SAFETY OF RECATICIMAB IN DYSLIPIDEMIA PATIENTS WITH OR WITHOUT TYPE 2 DIABETES MELLITUS: A POOLED PATIENT-LEVEL SUBGROUP ANALYSIS (ACC 2026) - "Recaticimab effectively lowers lipids and has a favorable safety profile in patients with dyslipidemia, regardless of T2DM status, supporting its use in both T2DM and non-T2DM populations."

Clinical • Diabetes • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia • Type 2 Diabetes Mellitus

EFFICACY AND SAFETY OF RECATICIMAB FOR LDL-C AND LIPOPROTEIN(A) REDUCTION: A SYSTEMATIC REVIEW AND META-ANALYSIS (ACC 2026) - "REMAIN-2 enrolled 689 patients with hypercholesterolemia on statins plus or minus ezetimibe; the 150 mg Q4W regimen (n=153 vs placebo n=78) demonstrated a treatment difference of -62.2% (95% CI -67.0 to -57.4) at week 24. Recaticimab significantly reduces LDL-C and Lp(a) compared with placebo, with consistent efficacy across different populations and background therapies. These findings support recaticimab as an effective lipid-lowering option; long-term cardiovascular outcome trials are warranted."

Retrospective data • Review • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

PISTIAS-3: PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (clinicaltrials.gov) - P4 | N=1212 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Ischemic stroke

Safety and Efficacy of Recaticimab in Dyslipidemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Pharmacotherapy) - "Recaticimab significantly reduced LDL-C levels and was associated with a manageable safety profile, even with dosing intervals of up to 12 weeks. Further studies should be conducted globally in larger and more diverse patient populations."

Clinical • Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Infectious Disease • Metabolic Disorders • Respiratory Diseases • APOB

Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Xiangya Hospital of Central South University

New P4 trial • Dermatology • Dyslipidemia • Immunology • Metabolic Disorders • Psoriasis

The Efficacy and Safety of Four Novel PCSK9 Monoclonal Antibodies in Patients With Hypercholesterolemia: A Systematic Review With Network Meta-Analysis and Trial Sequential Analysis. (PubMed, Cardiovasc Ther) - "These findings positioned ongericimab 150 mg Q2W as a clinically optimal PCSK9 inhibitor with robust lipid-lowering capacity. The results highlight the potential of next-generation PCSK9 monoclonal antibodies, particularly in East Asian populations, while underscoring the need for large-scale multinational trials to validate ethnic-specific responses."

Biomarker • Clinical • Journal • Retrospective data • Review • Dyslipidemia • Metabolic Disorders • APOB

EAST-LDL: Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion (clinicaltrials.gov) - P3 | N=652 | Recruiting | Sponsor: Shanghai East Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

INCLINE-AMI: Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period (clinicaltrials.gov) - P4 | N=2442 | Not yet recruiting | Sponsor: Second Affiliated Hospital of Nanchang University

New P4 trial • Cardiovascular • Myocardial Infarction

Comparative Efficacy of Ongericimab Versus Six PCSK9 Inhibitors in Treating Hypercholesterolemia or Mixed Dyslipidemia: A Network Meta-Analysis (ISPOR-EU 2025) - "This study aimed to assess the relative lipid-lowering efficacy of ongericimab compared with other PCSK9 inhibitors through a network meta-analysis (NMA). We conducted a systematic literature review (SLR) to identify phase 3 randomized controlled trials (RCTs) of ongericimab and six other PCSK9 inhibitors (evolocumab, alirocumab, tafolecimab, recaticimab, ebronucimab, and inclisiran) assessing efficacy in adult patients with hypercholesterolemia or mixed dyslipidemia, compared with background lipid-lowering therapies. Ongericimab demonstrated superior efficacy in reducing LDL-C and Lp(a) levels compared with most existing PCSK9 inhibitors. These findings may inform clinical decisions and support formulary positioning in lipid-lowering treatment strategies."

Retrospective data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Impact of PCSK9 Inhibitor Recaticimab on Hyperlipidemia and Plasma Glucose: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study. (PubMed, Biomed Environ Sci) - "For participants with normal and abnormal glucose metabolism, no significant group × time interaction effects on FPG or HbA1c levels were identified. Recaticimab showed no adverse glycemic effects in participants with normal or abnormal glucose metabolism, indicating its safety in patients with or without diabetes."

Clinical • Journal • P1/2 data • Diabetes • Dyslipidemia • Metabolic Disorders

Immunogenicity of Recaticimab Does Not Impact Its Efficacy in Patients with Dyslipidemia: A Pooled Analysis of Three Phase III and One Phase Ib/II Studies (AHA 2025) - P1/2 | "The incidence of ADAs (14.1%) and Nabs (3.2%) following recaticimab treatment did not impact efficacy. ADA+ and Nab+ patients had a higher incidence of self-resolving injection site reactions compared to ADA- patients. These findings support the clinical use of recaticimab for lipid-lowering therapy, regardless of immunogenicity status."

P1/2 data • P3 data • Retrospective data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

A phase II clinical study of adebrelimab in combination with chemotherapy and recaticimab for the treatment of immune checkpoint inhibitors pretreated NSCLC patients (ChiCTR) - P2 | N=43 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

Checkpoint inhibition • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Recaticimab in adult heterozygous familial hypercholesterolemia (REMAIN-3): A multicentre, randomised, double-blind, placebo-controlled phase 3 study. (PubMed, Cardiovasc Res) - P3 | "Recaticimab significantly lowered the LDL-C level compared with placebo, with an acceptable safety profile, providing a new effective treatment option for patients with inadequately controlled HeFH."

Journal • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOB

PICASSO: PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (clinicaltrials.gov) - P3 | N=5276 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P3 trial • Atherosclerosis

PISTIAS-2: PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Peking Union Medical College Hospital | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Sep 2025

Enrollment open • Trial initiation date • Atherosclerosis • Cardiovascular • Plasma NfL