SHR-1918 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P3 trial • Dyslipidemia • APOB

SHR-1918, an Angiopoietin-Like 3 Antibody, in Patients With Suboptimally Controlled Hyperlipidemia (AHA 2025) - "8 (26.7%) patients had SHR-1918-related TEAEs. There were no TEAEs leading to treatment discontinuation or death during the study.ConclusionSHR-1918 further reduced LDL-C and TG levels in hyperlipidemic patients on standard lipid-lowering therapies, providing a novel and safe treatment option for hyperlipidemia."

Clinical • Atherosclerosis • Dyslipidemia • ANGPTL3

Antibody-Based Therapeutics for Hypercholesterolemia. (PubMed, Biologics) - "In recent years the mAbs, alirocumab and evolocumab, targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have become established worldwide as an additional treatment for patients not achieving LDL cholesterol goals on statins and ezetimibe, or sometimes as an alternative treatment in those with statin intolerance...New drug targets were identified to potentially reduce elevated triglyceride levels and the mAb angiopoietin-like 3 (ANGPTL3) inhibitor, evinacumab, was found to be effective in reducing LDL cholesterol in patients with homozygous familial hypercholesterolemia (FH) and has been approved for that indication. SHR-1918 is another mAb targeting ANGPTL3 being developed in China which may also be effective to treat homozygous FH...Another mAb at an early stage of development is MAR001 targeting angiopoietin-like 4 (ANGPTL4). The role for this remains to be established."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders • ANGPTL3

ANGPTL3 Targeting Monoclonal Antibodies Lead to Robust Reductions in LDL-C, Triglycerides, ApoB, and Non-HDL-C in Dyslipidemic Patients: A Meta-Analysis of 5 Randomized Controlled Trials (AHA 2025) - "monoclonal antibodies targeting ANGPTL3 encompassing both evinacumab and the newer agent SHR-1918 consistently reduced LDL-C, triglycerides, and related lipid markers with a favourable tolerability profile. Further large, long-term studies are needed to fully establish their safety, clinical effectiveness, and potential to improve cardiovascular outcomes."

Retrospective data • Cardiovascular • Dyslipidemia • Metabolic Disorders • ANGPTL3 • APOB

Emerging ANGPTL3-directed therapies for hyperlipidemia: insights from two recent phase II trials. (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal • P2 data • Dyslipidemia • Hypertriglyceridemia • ANGPTL3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P3 | N=55 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2025 ➔ Aug 2025

Enrollment closed • Trial primary completion date • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P2 | N=26 | Completed | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Completed | N=20 ➔ 26

Enrollment change • Trial completion • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P2 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. (PubMed, Clin Pharmacokinet) - P1 | "SHR-1918 was well tolerated and showed promising efficacy in lipid reduction among healthy subjects."

Clinical • Journal • Dyslipidemia • ANGPTL3

Efficacy And Safety Of SHR-1918, An Angiopoietin-like 3 Monoclonal Antibody, In Combination With Lipid-lowering Therapy In Patients With Suboptimally Controlled Hyperlipidemia: A Multicenter, Randomized, Double Blind, Placebo-controlled Phase 2 Trial - Xiaojie Xie (ACC 2025) - No abstract available

Clinical • Combination therapy • Late-breaking abstract • P2 data • Dyslipidemia • ANGPTL3

Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia: A Phase 2 Study. (PubMed, J Am Coll Cardiol) - P2 | "Based on standard lipid-lowering therapy, ANGPTL-3 inhibition with SHR-1918 further reduces LDL-C by 21.7% to 29.9% in patients at moderate or higher risk of ASCVD. These additional reductions are both dose and dosing frequency dependent. (Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic; NCT06109831)."

Clinical • Journal • P2 data • Atherosclerosis • Cardiovascular • Dyslipidemia • ANGPTL3 • APOA1 • APOB • LPL

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P3 | N=45 | Recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia (clinicaltrials.gov) - P2 | N=44 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P3 | N=45 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P3 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

SHR-1918, a monoclonal antibody against angiopoietin-like 3, in healthy subjects: a randomized, double-blind, placebo-controlled, phase 1 study (ESC 2024) - P2 | "ConclusionsSHR-1918 was well-tolerated and showed promising efficacy in healthy subjects. A phase 2 study has initiated to evaluate SHR-1918 in hyperlipidemic patients (NCT06109831)."

Clinical • P1 data • Atherosclerosis • Cardiovascular • Dyslipidemia • ANGPTL3

Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P2 trial • Dyslipidemia

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic (clinicaltrials.gov) - P2 | N=335 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Combination therapy • New P2 trial

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P2 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Safety and Tolerability of SHR-1918 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • APOA1 • APOB

Safety and Tolerability of SHR-1918 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P1 trial • APOA1 • APOB