A Study of LY3561774 in Participants With Mixed Dyslipidemia

Phase 2 Completed 205 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.

Timeline

Start: 2022-07-20
Primary completion: 2024-03-04
Completion: 2024-05-23

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs LY3561774 400 mg; p = 0.008; Mean Difference (Net) -14.3 (95% CI -23.6 to -3.9); Mixed Models Analysis NCT05256654 ↗

paper Solbinsiran 400 mg reduced apoB in patients with mixed dyslipidaemia PMID 40179932 ↗

Publications

Ray KK, Oru E, Rosenson RS, Jones J, Ma X, Walgren J, Haupt A, Verma S, Gaudet D, Nicholls SJ, Ruotolo G. Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 May 3;405(10489):1594-1607. doi: 10.1016/S0140-6736(25)00507-0. Epub 2025 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Solbinsiran	Unknown	100 mg	Subcutaneous
Subject	Solbinsiran	Unknown	400 mg	Subcutaneous
Subject	Solbinsiran	Unknown	800 mg	Subcutaneous