First in Human Long-Acting Gene Silencing Therapy Significantly Lowers Heart Disease Risk Marker with One Injection
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August 28, 2026/News Releases
First in Human Long-Acting Gene Silencing Therapy Significantly Lowers Heart Disease Risk Marker with One Injection
Results suggest one shot could keep Lipoprotein(a) levels lower for nearly a year
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Medical illustration of Lipoprotein(a)
Findings from a Phase 1 clinical trial led by Cleveland Clinic show a single injection of Kylo-11 produced reductions in lipoprotein(a) levels, with the highest doses reducing levels by approximately 95–97% and maintained the reductions for 48 weeks.
Lipoprotein(a) is a key driver of heart disease and stroke that is typically considered an untreatable risk factor
Findings were presented today during a late-breaking science session at the European Society of Cardiology’s annual meeting in Munich and simultaneously published in the Lancet
Lipoprotein(a), commonly known as Lp(a), is a cholesterol-carrying particle produced primarily in the liver. It shares similarities with low-density lipoprotein (LDL), often referred to as “bad cholesterol,” but is largely controlled by genetics rather than lifestyle. In fact, about 80–90% of a person’s Lp(a) level is inherited. Because of its unique structure, elevated Lp(a) can contribute to the buildup of plaque in artery walls and increase the tendency for blood clots, raising the risk of heart attack and stroke.
While treatments that lower LDL cholesterol and other blood fats have significantly improved cardiovascular health, there are no approved medications specifically designed to lower Lp(a). Unlike LDL cholesterol, Lp(a) levels are not meaningfully reduced through diet, exercise or other lifestyle changes
The first-in-human, double blind, randomized trial enrolled 71 people in China, with 70 receiving a single injection of Kylo-11 or placebo and being followed for about 11 months. Kylo-11 uses a technology called small interfering RNAor siRNA and works by delivering a genetic “silencing” signal to liver cells, since the liver is where Lp(a) is produced. That signal then reduces production of apolipoprotein(a) or apo(a), a key building block of Lp(a). With less apo(a) being made, the body produces much less Lp(a). Results across the dosing groups showed a single injection reduced Lp(a) concentrations by approximately 53% to 97% at 48 weeks. Participants receiving the highest doses experienced reductions of about 95–97%, with the effect sustained for nearly one year.
“Most people with high Lp(a) don’t know it,” said lead author Ashish Sarraju, M.D., a cardiologist in the Heart, Vascular & Thoracic Institute at Cleveland Clinic
“Despite its significant impact on cardiovascular risk, Lp(a) is still underrecognized and undertested,” said Dr. Sarraju. “Improving awareness and routine testing will be critical as promising new therapies like this one emerge to potentially address this unmet need.”
A Phase 2 trial is underway by the sponsor of the Phase 1 trial, Kylonova Biopharma, in collaboration with Dr. Sarraju and Cleveland Clinic. Kylonova Biopharma is a subsidiary of Hygieia Pharma, an SBP GROUP company
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation, Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 83,000 employees worldwide are more than 6,600 salaried physicians and researchers, and 21,900 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,725-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 300 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2025, there were 15.9 million outpatient encounters, 343,000 hospital admissions and observations, and 336,000 surgeries and procedures throughout Cleveland Clinic’s health system. Visit us at clevelandclinic.org. Follow us at x.com/CleClinicNews. News and resources are available at newsroom.clevelandclinic.org.
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