ApoB: 14.3 percentage-point reduction vs placebo · Day 180 (25.7 weeks)
PROLONG-ANG3 · Phase 2 · Peer-reviewed trial · 400 mg on days 0 and 90 · Efficacy estimand among patients receiving at least one dose; placebo-adjusted percentage change.
Adverse events: 52% vs 65%; injection-site reactions: 5% vs 0% (400 mg/placebo). One ALT elevation ≥3 times normal occurred in each group; elevations were transient.
ApoB: 14.3 percentage-point reduction vs placebo · Day 180 (25.7 weeks)
400 mg on days 0 and 90
Mixed dyslipidemia despite statin therapy
Efficacy estimand among patients receiving at least one dose; placebo-adjusted percentage change.
Safety context
Adverse events: 52% vs 65%; injection-site reactions: 5% vs 0% (400 mg/placebo). One ALT elevation ≥3 times normal occurred in each group; elevations were transient.
Limitations: The 400 mg dose met the ApoB endpoint; the 800 mg dose did not. Clinical-event outcomes remain untested.
Status in this atlas: Current approval status is not summarized in this therapy record. A trial phase or a brand name does not establish approval for this use.
Uses RNA interference directed at ANGPTL3 messenger RNA to reduce ANGPTL3 production in the liver.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The conjugate class and target are verified in the primary trial. No exact whole-drug atomic model has been verified for this bundle; no generic RNA structure is substituted.
A next milestone is not summarized for this therapy. This does not mean development has ended.
Development history4 selected milestones
Solbinsiran · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
Study start
Phase 1 LY3561774 study starts
Lilly's trial record dates the start of the early human study to November 30, 2020. It assessed safety, tolerability, pharmacokinetics and lipid effects of the compound later named solbinsiran.
Lilly's trial record dates the start of the randomized phase 2 study in adults with mixed dyslipidemia despite statins. This is the study whose biomarker results and follow-up estimates appear on the lipid pages.
JACC published the early human dose-ranging results, reporting ANGPTL3 suppression and durable reductions in triglycerides and atherogenic lipoproteins. The paper also described supporting preclinical experiments.
The plotted phase 2 study reported a significant ApoB reduction at the 400-mg dose; the 800-mg dose did not meet that primary endpoint. The study measured lipid effects, not cardiovascular-event prevention.