Rachel V Thomas

Health and Me

Two Promising Heart Drugs Fail Late-Stage Trials: What Went Wrong?

Two experimental <span>heart drugs</span> developed by <span>Novartis</span> and <span>Novo Nordisk</span> have failed to reduce major cardiovascular events in separate late-stage trials, despite successfully targeting cholesterol and inflammation.

Novartis' <span>pelacarsen</span> lowered lipoprotein(a), or Lp(a), by 78%, while Novo Nordisk's <span>ziltivekimab</span> substantially reduced inflammatory markers. However, neither drug reduced heart attacks, strokes or cardiovascular deaths compared with a placebo.

"Everybody in the world, me included, thought that this was going to work," said Dr. Steven Nissen of Cleveland Clinic, presenting the pelacarsen results at the American Heart Association's Scientific Sessions 2026.

<h2>Novartis' Pelacarsen Fails To Reduce Heart Events</h2>

The seven-year Phase III Lp(a) HORIZON trial involved 8,323 people with established cardiovascular disease and elevated Lp(a) levels across 42 countries.

Participants received monthly injections of pelacarsen or a placebo. Despite reducing Lp(a) by 78%, the drug did not lower the risk of non-fatal heart attacks, strokes, urgent procedures to unblock arteries or cardiovascular deaths.

Even participants with higher Lp(a) levels showed no cardiovascular benefit.

"I cannot avoid the disappointing conclusion – it didn’t work," Nissen said, adding that cardiovascular outcomes remained unchanged despite the significant reduction in Lp(a).

<h2>Novo Nordisk's Ziltivekimab Also Fails</h2>

Novo Nordisk's Phase III ZEUS trial tested whether ziltivekimab, an experimental anti-inflammatory drug, could reduce cardiovascular events by blocking interleukin-6 (IL-6).

The trial included 6,376 patients with atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation.

In July 2026, Novo announced that the trial had failed to demonstrate a cardiovascular benefit. Results published in the <em>New England Journal of Medicine</em> on November 7 showed that although the drug substantially reduced inflammatory markers, it did not prevent major cardiovascular events.

During a median follow-up of 33 months, cardiovascular death, non-fatal heart attack or non-fatal stroke occurred in 17.6% of patients receiving ziltivekimab and 17.7% receiving placebo.

On September 7, Novo Nordisk discontinued two additional late-stage trials of ziltivekimab in patients with heart failure and inflammation.

An independent data monitoring committee recommended stopping the studies, concluding they were unlikely to succeed.

Nissen suggested that participants may have had advanced cardiovascular disease, making it too late for the drug to prevent further events.

Dr. Roger Blumenthal of Johns Hopkins suggested that participants' blood pressure and LDL cholesterol were already well controlled, leaving limited scope for additional risk reduction.

Another hypothesis was that anti-clotting medications taken by all participants may have diluted pelacarsen's potential effect, since Lp(a) is thought to contribute to cardiovascular disease partly by promoting blood clots.

These remain hypotheses, not proven explanations.

The findings also do not mean that Lp(a) or inflammation is irrelevant to heart disease. They show that lowering these markers with these particular drugs did not reduce cardiovascular events in the populations studied.

People with elevated Lp(a) can manage their cardiovascular risk by addressing other risk factors.

Nissen recommended exercise, weight management and lowering LDL cholesterol with statins when appropriate.

Three other cardiovascular outcome trials involving investigational Lp(a)-lowering drugs are underway. Their results may help determine whether targeting this cholesterol particle can prevent heart attacks and strokes.

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Two experimental heart drugs developed by Novartis and Novo Nordisk have failed to reduce major cardiovascular events in separate late-stage trials, despite successfully targeting cholesterol and inflammation.Novartis' pelacarsen lowered lipoprotein(a), or Lp(a), by 78%, while Novo Nordisk's ziltivekimab substantially reduced inflammatory markers. However, neither drug reduced heart attacks, strokes or cardiovascular deaths compared with a placebo."Everybody in the world, me included, thought that this was going to work," said Dr. Steven Nissen of Cleveland Clinic, presenting the pelacarsen results at the American Heart Association's Scientific Sessions 2026.Novartis' Pelacarsen Fails To Reduce Heart EventsThe seven-year Phase III Lp(a) HORIZON trial involved 8,323 people with established cardiovascular disease and elevated Lp(a) levels across 42 countries.Participants received monthly injections of pelacarsen or a placebo. Despite reducing Lp(a) by 78%, the drug did not lower the risk of non-fatal heart attacks, strokes, urgent procedures to unblock arteries or cardiovascular deaths.Even participants with higher Lp(a) levels showed no cardiovascular benefit."I cannot avoid the disappointing conclusion – it didn’t work," Nissen said, adding that cardiovascular outcomes remained unchanged despite the significant reduction in Lp(a).Novo Nordisk's Ziltivekimab Also FailsNovo Nordisk's Phase III ZEUS trial tested whether ziltivekimab, an experimental anti-inflammatory drug, could reduce cardiovascular events by blocking interleukin-6 (IL-6).The trial included 6,376 patients with atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation.In July 2026, Novo announced that the trial had failed to demonstrate a cardiovascular benefit. Results published in the New England Journal of Medicine on November 7 showed that although the drug substantially reduced inflammatory markers, it did not prevent major cardiovascular events.During a median follow-up of 33 months, cardiovascular death, non-fatal heart attack or non-fatal stroke occurred in 17.6% of patients receiving ziltivekimab and 17.7% receiving placebo.On September 7, Novo Nordisk discontinued two additional late-stage trials of ziltivekimab in patients with heart failure and inflammation.An independent data monitoring committee recommended stopping the studies, concluding they were unlikely to succeed.Why Did The Drugs Fail?Nissen suggested that participants may have had advanced cardiovascular disease, making it too late for the drug to prevent further events.Dr. Roger Blumenthal of Johns Hopkins suggested that participants' blood pressure and LDL cholesterol were already well controlled, leaving limited scope for additional risk reduction.Another hypothesis was that anti-clotting medications taken by all participants may have diluted pelacarsen's potential effect, since Lp(a) is thought to contribute to cardiovascular disease partly by promoting blood clots.These remain hypotheses, not proven explanations.The findings also do not mean that Lp(a) or inflammation is irrelevant to heart disease. They show that lowering these markers with these particular drugs did not reduce cardiovascular events in the populations studied.What Happens Next?People with elevated Lp(a) can manage their cardiovascular risk by addressing other risk factors.Nissen recommended exercise, weight management and lowering LDL cholesterol with statins when appropriate.Three other cardiovascular outcome trials involving investigational Lp(a)-lowering drugs are underway. Their results may help determine whether targeting this cholesterol particle can prevent heart attacks and strokes.

two promising heart drugs fail late-stage trials: what went wrong?

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