---
title: "Kylo-11 phase 1 trial: safety and durable reduction of lipoprotein(a) after single subcutaneous do"
id: "pubmed-42664979"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42664979"
content_type: "clinical_feed_article"
specialty: "Cardiology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42664979/"
doi: "10.1016/S0140-6736(26)01484-4"
published_at: "2026-09-05T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Kylo-11 phase 1 trial: safety and durable reduction of lipoprotein(a) after single subcutaneous do
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42664979
- **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42664979/)
- **DOI:** [10.1016/S0140-6736(26)01484-4](https://doi.org/10.1016%2FS0140-6736(26)01484-4)
- **Published At:** 2026-09-05T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This first-in-human, randomised, double-blind, placebo-controlled phase 1 trial evaluated **Kylo-11**, a non-canonical, long-duration small interfering RNA designed to lower **lipoprotein(a)**, in otherwise healthy adults with elevated Lp(a). - The study enrolled adults aged 18–55 at a single hospital site in China and randomized participants 8:2 to receive a single subcutaneous dose of Kylo-11 or placebo across seven dosing cohorts. - Dosing cohorts included 9, 30, 75, 225, 450, and 600 mg for participants with baseline Lp(a) 75–200 nmol/L; an additional cohort (cohort 7) gave 225 mg to participants with baseline Lp(a) >200 nmol/L. - Primary endpoint was incidence of investigator-assessed adverse events within 24 weeks; safety analysis included all dosed participants; pharmacodynamic analysis included those with at least one post-dose PD datapoint. - 71 participants were randomised between May 30 and Dec 30, 2024; 70 received study drug (57 Kylo-11, 14 placebo). Median age 27.5 years; 65% male. Median follow-up was 337 days. - Adverse events up to 24 weeks occurred in 53% (37/70) and were mostly grade 1–2 and judged unrelated to study drug. There were no injection-site reactions, no drug-related adverse events, no serious adverse events, and no deaths. - Three grade ≥3 events were adjudicated unrelated to Kylo-11: two in Kylo-11 225 mg cohort (transient hypertriglyceridaemia and elevated creatine phosphokinase on day 168) and one in placebo (transient hypertriglyceridaemia on day 84). - Pharmacodynamic results at 48 weeks showed dose-dependent median percent reductions in serum Lp(a): from –53% at 9 mg up to –97% at 600 mg; absolute median reductions ranged from –71 nmol/L (9 mg) to –129 nmol/L (600 mg). - In cohort 7 (225 mg with baseline Lp(a)>200 nmol/L) median reduction at 48 weeks was –96% (–208 nmol/L), indicating substantial absolute and relative reductions in very high baseline Lp(a). - Interpretation: a single subcutaneous dose of Kylo-11 was well tolerated and produced durable reductions in serum Lp(a) for up to 48 weeks at doses ≥225 mg. Funding was provided by Kylonova Biopharma. - Conflict of interest disclosures: several authors are employees or inventors with Hygieia Pharmaceuticals or Kylonova; some authors have roles in other Lp(a) trials or industry relationships; other authors declared no competing interests.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 28. # Safety and lipoprotein(a)-lowering effects of Kylo-11, a non-canonical, long-duration small interfering RNA targeting lipoprotein(a): a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial [Ashish Sarraju](https://pubmed.ncbi.nlm.nih.gov/?term=Sarraju+A&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Xiaolin Du](https://pubmed.ncbi.nlm.nih.gov/?term=Du+X&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Luping Zhou](https://pubmed.ncbi.nlm.nih.gov/?term=Zhou+L&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Luke J Laffin](https://pubmed.ncbi.nlm.nih.gov/?term=Laffin+LJ&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Kathy Wolski](https://pubmed.ncbi.nlm.nih.gov/?term=Wolski+K&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Yumei Gu](https://pubmed.ncbi.nlm.nih.gov/?term=Gu+Y&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Ziyang Liu](https://pubmed.ncbi.nlm.nih.gov/?term=Liu+Z&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Qinsheng Zhang](https://pubmed.ncbi.nlm.nih.gov/?term=Zhang+Q&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Kunyuan Cui](https://pubmed.ncbi.nlm.nih.gov/?term=Cui+K&cauthor_id=42664979)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-4 "Hygieia Pharmaceuticals Co, Hangzhou, China; Kylonova \(Xiamen\) Biopharma Co, Xiamen, China."), [Xiaolan Yong](https://pubmed.ncbi.nlm.nih.gov/?term=Yong+X&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Steven E Nissen](https://pubmed.ncbi.nlm.nih.gov/?term=Nissen+SE&cauthor_id=42664979)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#full-view-affiliation-5 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. Electronic address: nissens@ccf.org.") Affiliations Expand ### Affiliations * 1 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. * 2 Chengdu Xinhua Hospital, Sichuan, China. * 3 Hygieia Pharmaceuticals Co, Hangzhou, China. * 4 Hygieia Pharmaceuticals Co, Hangzhou, China; Kylonova (Xiamen) Biopharma Co, Xiamen, China. * 5 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. Electronic address: nissens@ccf.org. * PMID: **42664979** * DOI: [ 10.1016/S0140-6736(26)01484-4 ](https://doi.org/10.1016/s0140-6736\(26\)01484-4) Item in Clipboard Clinical Trial # Safety and lipoprotein(a)-lowering effects of Kylo-11, a non-canonical, long-duration small interfering RNA targeting lipoprotein(a): a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial Ashish Sarraju et al. Lancet. 2026. Show details Display options Display options Format Abstract PubMed PMID Lancet Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Lancet%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Lancet%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42664979/) . 2026 Sep 5;408(10558):899-909. doi: 10.1016/S0140-6736(26)01484-4. Epub 2026 Aug 28. ### Authors [Ashish Sarraju](https://pubmed.ncbi.nlm.nih.gov/?term=Sarraju+A&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Xiaolin Du](https://pubmed.ncbi.nlm.nih.gov/?term=Du+X&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Luping Zhou](https://pubmed.ncbi.nlm.nih.gov/?term=Zhou+L&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Luke J Laffin](https://pubmed.ncbi.nlm.nih.gov/?term=Laffin+LJ&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Kathy Wolski](https://pubmed.ncbi.nlm.nih.gov/?term=Wolski+K&cauthor_id=42664979)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-1 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA."), [Yumei Gu](https://pubmed.ncbi.nlm.nih.gov/?term=Gu+Y&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Ziyang Liu](https://pubmed.ncbi.nlm.nih.gov/?term=Liu+Z&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Qinsheng Zhang](https://pubmed.ncbi.nlm.nih.gov/?term=Zhang+Q&cauthor_id=42664979)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-3 "Hygieia Pharmaceuticals Co, Hangzhou, China."), [Kunyuan Cui](https://pubmed.ncbi.nlm.nih.gov/?term=Cui+K&cauthor_id=42664979)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-4 "Hygieia Pharmaceuticals Co, Hangzhou, China; Kylonova \(Xiamen\) Biopharma Co, Xiamen, China."), [Xiaolan Yong](https://pubmed.ncbi.nlm.nih.gov/?term=Yong+X&cauthor_id=42664979)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-2 "Chengdu Xinhua Hospital, Sichuan, China."), [Steven E Nissen](https://pubmed.ncbi.nlm.nih.gov/?term=Nissen+SE&cauthor_id=42664979)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42664979/#short-view-affiliation-5 "Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. Electronic address: nissens@ccf.org.") ### Affiliations * 1 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. * 2 Chengdu Xinhua Hospital, Sichuan, China. * 3 Hygieia Pharmaceuticals Co, Hangzhou, China. * 4 Hygieia Pharmaceuticals Co, Hangzhou, China; Kylonova (Xiamen) Biopharma Co, Xiamen, China. * 5 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, OH, USA. Electronic address: nissens@ccf.org. * PMID: **42664979** * DOI: [ 10.1016/S0140-6736(26)01484-4 ](https://doi.org/10.1016/s0140-6736\(26\)01484-4) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Elevated lipoprotein(a) concentrations are associated with the development of atherosclerotic cardiovascular disease. The aim of this study was to evaluate the safety and lipoprotein(a)-lowering effects of Kylo-11, a very long-acting small interfering RNA that targets lipoprotein(a). **Methods:** This randomised, double-blind, placebo-controlled, phase 1 trial was performed in a single hospital-based site in China in adults aged 18-55 years with elevated lipoprotein(a) concentrations who were otherwise healthy. Participants were randomly assigned to receive a single, subcutaneous dose of Kylo-11 or placebo (8:2) across seven dosing cohorts. Kylo-11 recipients could enter conditional extension follow-up up to day 337, whereas placebo recipients were followed up to day 169. Participants with lipoprotein(a) concentrations of 75-200 nmol/L were enrolled into cohorts 1-6 (ie, doses of 9, 30, 75, 225, 450, and 600 mg). Participants with lipoprotein(a) concentrations of more than 200 nmol/L were enrolled into cohort 7 (225 mg). The randomisation schedule was generated by an unmasked statistician with no involvement in study conduct, efficacy or safety analyses, or blinded data analysis, and assigned to treatment groups by an interactive web response system. Participants, investigators, and study personnel were masked to cohort assignment. The primary endpoint was the incidence of investigator-assessed adverse events within 24 weeks. All randomly assigned participants who received a dose of investigational product were included in the safety analysis set. All randomly assigned participants who received a dose of Kylo-11 and had at least one pharmacodynamic datapoint were included in the pharmacodynamic analysis set. Missing data were not imputed. The trial was registered on ClinicalTrials.gov ([NCT06363851](http://clinicaltrials.gov/show/NCT06363851 "See in ClinicalTrials.gov")) and is now complete. **Findings:** Between May 30, 2024, and Dec 30, 2024, 71 participants were randomly assigned to the Kylo-11 cohorts (n=57) or the placebo cohort (n=14) and 70 participants received a dose. The median age of participants was 27·5 years (IQR 22·0-32·0), and 46 (65%) participants were male and 25 (35%) were female. Participants were followed up for a median of 337 days (IQR 334-337). 37 (53%) of 70 participants had adverse events up to 24 weeks, the majority of which were grade 1-2 and deemed unrelated to the study drug by the investigators. There were no injection-site reactions, no serious adverse events, no drug-related adverse events, and no deaths. Two grade 3 or higher events (ie, transient hypertriglyceridaemia at day 168 and elevated creatine phosphokinase at day 168) in the 225 mg cohort were adjudicated as unrelated to the study drug; one grade 3 or higher event (transient hypertriglyceridaemia) occurred in the placebo group at day 84. The prespecified pharmacodynamic secondary endpoints of median percent and absolute reductions in serum lipoprotein(a) over time at the final follow-up timepoint of 48 weeks for the Kylo-11 groups ranged from -53% (IQR -71 to -41) and -71 nmol/L (-79 to -60) in the 9 mg cohort to -97% (-98 to -97) and -129 nmol/L (-153 to -99) in the 600 mg cohort. In cohort 7 (225 mg; baseline lipoprotein(a) >200 nmol/L), the median reductions were -96% (-98 to -91) and -208 nmol/L (-222 to -198). **Interpretation:** A single dose of Kylo-11 was well tolerated, and at doses of 225 mg or higher, durably reduced serum lipoprotein(a) concentrations up to 48 weeks. **Funding:** Kylonova Biopharma. Copyright © 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of interests YG, ZL, QZ, and KC are employees of Hygieia Pharmaceuticals. YG had a dual role as a coauthor of the manuscript with affiliation to Hygieia Pharmaceuticals while also appearing as Medical Director and sponsor signatory on the protocol and statistical analysis plan. YG, QZ, and KC are inventors of submitted patent PCT/CN2026/092548. KC is the inventor of submitted patents PCT/CN2023/080708 and PCT/CN2023/125861. SEN is the Executive Committee Chair for the phase 3 pelacarsen, lepodisiran, and muvalaplin trials, is the lead author of the phase 1 and 2 trials of lepodisiran and zerlasiran, and has received grants and meeting or travel support from Eli Lilly, Novartis, and Silence Therapeutics. LJL is a co-investigator for the phase 3 lepodisiran trials and previously served as an investigator for a phase 2 olpasiran trial and has received grants from Lilly and Amgen. AS is a co-investigator for the phase 3 olpasiran trial. All other authors declare no competing interests. ## Similar articles * [ Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. ](https://pubmed.ncbi.nlm.nih.gov/27665230/) Viney NJ, van Capelleveen JC, Geary RS, Xia S, Tami JA, Yu RZ, Marcovina SM, Hughes SG, Graham MJ, Crooke RM, Crooke ST, Witztum JL, Stroes ES, Tsimikas S.Viney NJ, et al.Lancet. 2016 Nov 5;388(10057):2239-2253. doi: 10.1016/S0140-6736(16)31009-1. Epub 2016 Sep 21.Lancet. 2016.PMID: 27665230Clinical Trial. * [ The small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729-001): a phase 1a/b trial. ](https://pubmed.ncbi.nlm.nih.gov/42173110/) Yuen MF, Gane E, Holmes JA, Strasser SI, Lee
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