Key result
SHR-1918 reduces LDL-C by ~23% vs. placebo in refractory hyperlipidemia.
Why the study?
The efficacy and safety of SHR-1918 administered once every 12 weeks in patients with hyperlipidemia inadequately controlled by statins was unknown.
Does the ANGPTL3 antibody SHR-1918, administered once every 12 weeks, reduce LDL-C and triglyceride levels in hyperlipidemic patients suboptimally controlled on standard lipid-lowering therapies?
RCT (n=44)
Double-blind
Block randomization
Yes
Does the ANGPTL3 antibody SHR-1918, administered once every 12 weeks, reduce LDL-C and triglyceride levels in hyperlipidemic patients suboptimally controlled on standard lipid-lowering therapies?
SHR-1918 administered subcutaneously once every 12 weeks significantly reduced LDL-C and triglyceride levels in patients with hyperlipidemia inadequately controlled on statin therapy, with a favorable safety profile.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The core advantage of SHR-1918 lies in its unique target of action by inhibiting ANGPTL-3 while enhancing the activity of LPL and EL, which achieves dual regulation of LDL-C and TG. The findings of this study support that SHR-1918 could be a novel treatment option for patients with moderate or higher risk of ASCVD who have not achieved optimal lipid control and need additional lipid reduction beyond statins and other lipid-lowering therapies.”
“the efficacy of ANGPTL3 inhibition is highly dependent on the patients' baseline lipid levels.”
“intravenous infusion is inconvenient, poses challenges for pediatric patients, and shows risks of infusion-related reactions, phlebitis, and local infections. In contrast, SHR-1918 can be administered subcutaneously.”
Supports 12-week SHR-1918 dosing for LDL-C reduction on statins; extends phase 2 efficacy to longer intervals.
BACKGROUND: SHR-1918 is a long-acting angiopoietin-like 3 antibody with established lipid-lowering efficacy at 600 mg once every 4 weeks or once every 8 weeks. OBJECTIVES: This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of SHR-1918 at an extended dosing interval (once every 12 weeks) in patients with hyperlipidemia. METHODS: Patients who did not achieve their low-density lipoprotein cholesterol (LDL-C) targets after statin run-in were randomized (2:1) to receive subcutaneous SHR-1918 (600 or 1,200 mg) or placebo once every 12 weeks for 24 weeks. The primary endpoint was percent change in LDL-C from baseline to week 24. RESULTS: Forty-four patients were randomized to SHR-1918 600 mg (n = 14), SHR-1918 1,200 mg (n = 16), or placebo (n = 14). At week 24, the percent change in LDL-C from baseline was -20.8% (95% CI: -28.4 to -13.1), -25.1% (95% CI: -32.4 to -17.7), and -2.2% (95% CI: -10.1 to 5.7) in the 3 groups, respectively. The between-group difference (SHR-1918 vs placebo) was -18.6% (95% CI: -29.5 to -7.6; P = 0.0015) for 600 mg and -22.9% (95% CI: -33.7 to -12.1; P = 0.0001) for 1,200 mg. The percent change in triglyceride was -49.8% (95% CI: -61.7 to -37.9) and -58.8% (95% CI: -70.3 to -47.3) with SHR-1918 600 mg and 1,200 mg compared with -1.2% (95% CI: -13.6 to 11.2) with placebo, showing between-group differences of -48.6% (95% CI: -65.8 to -31.4; P < 0.0001) and -57.6% (95% CI: -74.6 to -40.6; P < 0.0001). CONCLUSIONS: SHR-1918, at a once every 12 weeks dosing frequency, further reduced LDL-C and triglyceride levels in hyperlipidemic patients inadequately controlled with background lipid-lowering therapies. (Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control; NCT06471218).
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Zhong et al. (2026) conducted an RCT in Hyperlipidemia (n=44). SHR-1918 vs. Placebo was evaluated on Percent change in serum LDL-C from baseline to week 24 (MD -22.9%, 95% CI -33.7 to -12.1, p=0.0001). SHR-1918 at 1,200 mg once every 12 weeks significantly reduced LDL-C by a placebo-adjusted 22.9% at 24 weeks in patients with hyperlipidemia inadequately controlled with standard therapies.
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