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VERVE-102 Shows Durable LDL Reduction in Heart-2 Study, Lilly Plans Phase 2 Launch

Eli Lilly has released early clinical results for its gene-editing candidate VERVE-102, highlighting the potential of a single-dose treatment to deliver sustained reductions in LDL cholesterol among high-risk patients.

The investigational therapy targets the PCSK9 gene in the liver, aiming to permanently reduce its activity and lower circulating cholesterol levels. In the ongoing Phase 1b Heart-2 study, VERVE-102 is being evaluated in patients with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease who require additional LDL-C lowering despite existing treatments.

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Data from 35 participants show a clear dose-response relationship. LDL cholesterol reductions varied across dose cohorts, with decreases of 9% at 0.3 mg/kg, 44% at 0.45 mg/kg, 45% at 0.6 mg/kg, 33% at 0.7 mg/kg, 51% at 0.8 mg/kg, and up to 62% at the highest dose of 1.0 mg/kg. In parallel, PCSK9 protein levels declined substantially, reaching reductions of up to 88% at higher dose levels.

Notably, these effects were not short-lived. Follow-up data indicate that cholesterol lowering has been maintained for as long as 18 months in some patients, suggesting the possibility of a durable, one-time treatment approach.

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VERVE-102 uses an in vivo gene-editing strategy designed to replicate the protective effect seen in individuals with naturally occurring PCSK9 loss-of-function mutations, which are associated with lower lifetime cardiovascular risk. The therapy is delivered via lipid nanoparticles carrying genetic instructions that selectively target liver cells.

The Heart-2 trial is continuing to assess safety and long-term outcomes, with participants monitored over extended periods. Based on the current findings, Lilly plans to initiate a Phase 2 study later this year to further evaluate the therapy’s efficacy and safety profile.

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Global POSEIDON study shows cardiovascular inflammation affects 2 in 5 patients with heart disease, kidney disease or heart failure

A large international analysis has found that cardiovascular inflammation remains common in people already being treated for cardiovascular disease, exposing a substantial residual risk of heart attack and stroke. The findings come from POSEIDON, a global real‑world study including nearly 19,000 patients across 18 countries.

High inflammatory burden despite treatment

POSEIDON evaluated people with established cardiovascular disease who were receiving what would typically be considered standard, guideline‑recommended care. Yet, the data showed that inflammation affecting the heart and blood vessels was still widespread in this population. Around two in five individuals with atherosclerotic cardiovascular disease and chronic kidney disease, and a similar proportion of those with heart failure, had evidence of ongoing cardiovascular inflammation.

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Cardiovascular inflammation is not just a bystander. It is recognised as an independent driver of major cardiovascular events such as heart attack, stroke and cardiovascular death. The new results highlight that, even when traditional risk factors such as cholesterol, blood pressure and blood sugar are managed, inflammation‑related risk can remain.

Study scale and patient groups

The POSEIDON programme enrolled 18,904 patients between 2023 and 2025 from Europe, North America, South America and the Asia‑Pacific region. Within this cohort, 13,475 participants had atherosclerotic cardiovascular disease. Of these, 5,757 were also living with chronic kidney disease. Another 11,809 participants had heart failure, spanning the full spectrum of heart failure phenotypes, including preserved, mildly reduced and reduced ejection fraction.

A separate analysis from POSEIDON, recently reported in a leading cardiology journal, focused specifically on heart failure and similarly found that about two in five people with heart failure showed signs of cardiovascular inflammation. This pattern was consistent across heart failure subtypes and was especially prominent in patients with obesity, kidney disease or other metabolic disorders.