{"id":138536,"date":"2026-07-31T22:00:31","date_gmt":"2026-07-31T22:00:31","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/138536\/"},"modified":"2026-07-31T22:00:31","modified_gmt":"2026-07-31T22:00:31","slug":"novo-nordisk-zeus-trial-no-mace-benefit-hr-0-99","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/138536\/","title":{"rendered":"Novo Nordisk ZEUS Trial: No MACE Benefit, HR 0.99"},"content":{"rendered":"<p>&#13;<br \/>\n    &#13;<br \/>\n&#13;<\/p>\n<p>Novo Nordisk (NYSE:NVO) reported headline results from the phase 3 ZEUS cardiovascular outcomes trial of once\u2011monthly ziltivekimab 15 mg in over 6,300 people with ASCVD, CKD and inflammation (hsCRP \u22652 mg\/L). Ziltivekimab showed IL\u20116 pathway target engagement, with expected reductions in free IL\u20116 and hsCRP, but did not reduce major adverse cardiovascular events (MACE) versus placebo (hazard ratio 0.99; 95% CI 0.88\u20131.11).<\/p>\n<p>Overall adverse event and serious adverse event rates were similar between ziltivekimab and placebo, though serious infections were more frequent with ziltivekimab, and no difference in all\u2011cause mortality was observed. The outcome will trigger a non\u2011cash impairment charge in Q3 2026 but will not affect the company\u2019s adjusted operating profit outlook for 2026. Ongoing cardiovascular outcomes trials HERMES (heart failure) and ARTEMIS (post\u2011acute heart attack) are planned to continue, with readouts expected in the first half of 2027.<\/p>\n<p>\n            Loading&#8230;\n          <\/p>\n<p>          Loading translation&#8230;<\/p>\n<p>          Positive<\/p>\n<p>                    Overall AE and serious AE rates similar between ziltivekimab and placebo<\/p>\n<p>                    2026 adjusted operating profit outlook unchanged despite ZEUS outcome<\/p>\n<p>                    Two additional ziltivekimab CVOTs (HERMES, ARTEMIS) continue with readouts expected H1 2027<\/p>\n<p>          Negative<\/p>\n<p>                    Primary endpoint missed: no MACE risk reduction vs placebo (HR 0.99; 95% CI 0.88\u20131.11)<\/p>\n<p>                    Higher serious infection rate in ziltivekimab group vs placebo<\/p>\n<p>                    Non\u2011cash impairment charge expected in Q3 2026 related to ZEUS outcome<\/p>\n<p>&#13;<br \/>\n      -0.14%&#13;<br \/>\n      Vs previous close&#13;\n    <\/p>\n<p>&#13;<br \/>\n        $47.09&#13;<br \/>\n        Last Price&#13;\n      <\/p>\n<p>&#13;<br \/>\n        &#13;<br \/>\n          $45.37&#13;<br \/>\n          $51.12&#13;<br \/>\n        &#13;<br \/>\n        Day Range&#13;\n      <\/p>\n<p>&#13;<br \/>\n        $208.23B&#13;<br \/>\n        Market Cap&#13;\n      <\/p>\n<p>&#13;<br \/>\n        3.0x&#13;<br \/>\n        Rel. Volume&#13;\n      <\/p>\n<p class=\"argus-explanation-text\">&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      Following this news, NVO has declined 0.14%, reflecting a mild negative market reaction.&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      Our momentum scanner has triggered 23 alerts so far, indicating elevated trading interest and price volatility.&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      The stock is currently trading at $47.09.&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      Trading volume is very high at 3.0x the average, suggesting heavy selling pressure.&#13;<br \/>\n      &#13;<br \/>\n      &#13;\n    <\/p>\n<p class=\"argus-source\">&#13;<br \/>\n      Data tracked by <a href=\"https:\/\/www.stocktitan.net\/scanner\/momentum\" class=\"argus-link\" rel=\"nofollow noopener\" target=\"_blank\">StockTitan Argus<\/a> (15 min delayed). <a href=\"https:\/\/www.stocktitan.net\/pricing\" class=\"argus-upgrade-link\" rel=\"nofollow noopener\" target=\"_blank\">Upgrade to Gold<\/a> for real-time data.&#13;\n    <\/p>\n<p class=\"context-narrative-text\">\n      NVO had low short positioning in current risk data, providing context without establishing a directional catalyst. ZEUS remains a clinical readout with safety findings and follow-on trial milestones requiring monitoring.\n    <\/p>\n<p>\n        MACE hazard ratio<br \/>\n        0.99<\/p>\n<p>        ZEUS Phase 3 trial versus placebo<\/p>\n<p>\n        95% confidence interval<br \/>\n        0.88 to 1.11<\/p>\n<p>        MACE hazard ratio<\/p>\n<p>\n        Trial enrollment<br \/>\n        over 6,300 people<\/p>\n<p>        ZEUS Phase 3 trial<\/p>\n<p>\n        hsCRP threshold<br \/>\n        \u22652 mg\/L<\/p>\n<p>        Inflammation eligibility criterion<\/p>\n<p>\n        Ziltivekimab dose<br \/>\n        15 mg<\/p>\n<p>        Once-monthly treatment versus placebo<\/p>\n<p>\n        Non-cash impairment charge<br \/>\n        Q3 2026<\/p>\n<p>        Resulting from the ZEUS outcome<\/p>\n<p>\n        Additional trial readouts<br \/>\n        First half of 2027<\/p>\n<p>        HERMES and ARTEMIS cardiovascular outcomes trials<\/p>\n<p>            Date<br \/>\n            Event<br \/>\n            Sentiment<br \/>\n            24h Move<br \/>\n            Catalyst<\/p>\n<p>            Mar 19<\/p>\n<p>                <a href=\"https:\/\/www.stocktitan.net\/news\/NVO\/fda-approves-novo-nordisk-s-new-wegovy-hd-injection-delivering-the-lf6ib2uell2e.html\" rel=\"nofollow noopener\" target=\"_blank\">FDA approval<\/a><\/p>\n<p>              Positive<\/p>\n<p>              -1.0%<\/p>\n<p>              FDA approved Wegovy HD after reported weight-loss results and expanded obesity treatment options.<\/p>\n<p>        Pattern Detected<\/p>\n<p class=\"context-pattern-text\">The available prior event showed a negative reaction to favorable FDA approval news, indicating divergence from the announcement&#8217;s positive fundamentals.<\/p>\n<p>          hazard ratio<\/p>\n<p>          medical<\/p>\n<p>&#8220;hazard ratio, 0.99; 95% confidence interval, 0.88 to 1.11&#8221;<\/p>\n<p>A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.<\/p>\n<p>          confidence interval<\/p>\n<p>          medical<\/p>\n<p>&#8220;95% confidence interval, 0.88 to 1.11&#8221;<\/p>\n<p>An interval estimate that shows a range of values within which a true number (like a company\u2019s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band\u2014like a weather forecast saying 60\u201370\u00b0F instead of just 65\u00b0F\u2014making uncertainty explicit so you can judge risk and size positions more sensibly.<\/p>\n<p>          mace<\/p>\n<p>          medical<\/p>\n<p>&#8220;major adverse cardiovascular events (MACE) risk reduction&#8221;<\/p>\n<p>MACE stands for Major Adverse Cardiovascular Events \u2014 a composite medical endpoint that counts serious heart-related outcomes such as heart attack, stroke and cardiovascular death. Investors use MACE as a single safety and efficacy yardstick for drugs or devices aimed at the heart or blood vessels; like a vehicle crash-test score, a lower MACE rate signals fewer serious harms and can strongly influence regulatory approval, market adoption and commercial value.<\/p>\n<p>          monoclonal antibody<\/p>\n<p>          medical<\/p>\n<p>&#8220;Ziltivekimab is an investigational, fully human monoclonal antibody&#8221;<\/p>\n<p>A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.<\/p>\n<p class=\"context-ai-disclaimer\">AI-generated analysis. <a href=\"https:\/\/www.stocktitan.net\/rhea-ai.html\" rel=\"nofollow noopener\" target=\"_blank\">How Rhea-AI works<\/a>. Not financial advice.<\/p>\n<p>&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n    &#13;<br \/>\n&#13;<br \/>\n&#13;<\/p>\n<p>  <img decoding=\"async\" class=\"ps-bar__icon\" src=\"https:\/\/static.stocktitan.net\/img\/icons\/Google_News_icon.svg\" width=\"24\" height=\"24\" alt=\"\" loading=\"lazy\" aria-hidden=\"true\"\/><\/p>\n<p>&#13;<br \/>\n    &#13;<br \/>\n    See more from StockTitan in Google Search and AI answers.&#13;<br \/>\n    Adds StockTitan as a preferred source \u00b7 opens Google&#13;\n  <\/p>\n<p>&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n    &#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n      07\/31\/2026 &#8211; 07:20 AM&#13;<br \/>\n    &#13;<br \/>\n&#13;<\/p>\n<p>Bagsv\u00e6rd, Denmark, 31 July 2026 \u2013 Novo Nordisk\u00a0today announced headline results from the ZEUS cardiovascular outcomes phase 3 trial.<\/p>\n<p>While ziltivekimab demonstrated target engagement and inhibition of the IL-6 pathway, as reflected by expected reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP) respectively, this did not translate into major adverse cardiovascular events (MACE) risk reduction versus placebo in people with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and inflammation (hazard ratio, 0.99; 95% confidence interval, 0.88 to 1.11)1.<\/p>\n<p>ZEUS was a double-blind, placebo-controlled trial enrolling over 6,300 people with ASCVD, CKD, and inflammation, as measured by hsCRP levels \u22652 mg\/L. The trial evaluated once-monthly ziltivekimab 15 mg versus placebo for reducing the risk of MACE, defined as cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke.<\/p>\n<p>\u201cZEUS was designed to test whether inhibition of the IL-6 pathway could translate reductions in cardiovascular inflammation into fewer major cardiovascular events. Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,\u201d said Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development at Novo Nordisk. \u201cWhile ziltivekimab did not achieve the MACE benefit we had hoped for, this does not change our strategic commitment to cardiovascular disease. The study provides important scientific evidence that will inform our ongoing cardiovascular research and the development of treatments for patients who continue to face substantial unmet need.\u201d<\/p>\n<p>Overall rates of adverse events (AEs) and serious AEs in people treated with ziltivekimab were similar to those observed with placebo. Consistent with targeting IL-6 inhibition, a higher proportion of people treated with ziltivekimab had serious infections compared to placebo. No difference in all-cause mortality was observed.<\/p>\n<p>The two additional ongoing cardiovascular outcomes trials investigating ziltivekimab in people with heart failure (HERMES) and in people following an acute heart attack (ARTEMIS) are planned to continue and are anticipated to read out in the first half of 2027.<\/p>\n<p>The outcome of ZEUS will not impact Novo Nordisk\u2019s previously communicated adjusted operating profit outlook for 2026 but will result in a non-cash impairment charge in Q3 2026.<\/p>\n<p>Full results of the ZEUS trial will be presented at an upcoming scientific meeting in 2026.<\/p>\n<p>About ziltivekimab<br \/>Ziltivekimab is an investigational, fully human monoclonal antibody that targets the IL\u20116 ligand, a pro-inflammatory cytokine, to reduce cardiovascular inflammation and improve cardiovascular outcomes. It is being developed by Novo Nordisk for conditions such as cardiovascular disease, acute myocardial infarction (AMI) and heart failure with preserved ejection fraction (HFpEF).<\/p>\n<p>About ZEUS <br \/>ZEUS \u2013 an event\u2011driven cardiovascular outcomes trial investigating efficacy and safety with once-monthly subcutaneous ziltivekimab 15 mg versus placebo on top of standard of care in people with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and CV inflammation (hsCRP\u00a0\u2265\u00a02\u00a0mg\/L).<\/p>\n<p>Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk&#8217;s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (<a href=\"https:\/\/www.stocktitan.net\/overview\/NVO\/\" title=\"View NVO stock overview\" class=\"symbol-link\" rel=\"nofollow noopener\" target=\"_blank\">NVO<\/a>). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.<\/p>\n<p>Publication of inside information\u00a0pursuant to\u00a0Market Abuse Regulation, Article 17.\u00a0<\/p>\n<p>Contacts for further information<\/p>\n<p>Company announcement No 45 \/ 2026<\/p>\n<p>1 Time to first occurrence of 3-point MACE \u2013 primary endpoint analysis \u2013 Cox regression \u2013 in-study \u2013 full analysis set<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.europesays.com\/dk\/wp-content\/uploads\/2026\/07\/1785535230_850_ti.gif\"\/> <br \/><img decoding=\"async\" loading=\"lazy\" alt=\"\" src=\"https:\/\/www.europesays.com\/dk\/wp-content\/uploads\/2026\/07\/1785535231_126_Novo-Nordisk-A-S.png\" referrerpolicy=\"no-referrer-when-downgrade\"\/>&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n      &#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n  &#13;<br \/>\n&#13;<\/p>\n<p>&#13;<br \/>\n    FAQ  &#13;\n  <\/p>\n<p>&#13;<br \/>\n  &#13;<br \/>\n  &#13;<\/p>\n<p>        What did Novo Nordisk (NVO) announce about the ZEUS phase 3 trial results?<\/p>\n<p>&#13;<br \/>\n          Novo Nordisk reported that ziltivekimab did not reduce major adverse cardiovascular events versus placebo in ZEUS. According to Novo Nordisk, the hazard ratio for MACE was 0.99 with a 95% confidence interval of 0.88 to 1.11 in people with ASCVD, CKD and inflammation.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        Did ziltivekimab show a cardiovascular benefit in the ZEUS trial for Novo Nordisk (NVO)?<\/p>\n<p>&#13;<br \/>\n          Ziltivekimab did not show a MACE risk reduction compared to placebo in ZEUS. According to Novo Nordisk, the hazard ratio for three\u2011point MACE was 0.99 (95% CI 0.88\u20131.11), indicating no cardiovascular outcome benefit in this studied population despite observed IL\u20116 pathway inhibition.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        How did ziltivekimab affect safety outcomes in the ZEUS phase 3 trial reported by Novo Nordisk (NVO)?<\/p>\n<p>&#13;<br \/>\n          Overall adverse event and serious adverse event rates were similar between ziltivekimab and placebo. According to Novo Nordisk, serious infections occurred more often with ziltivekimab, consistent with IL\u20116 inhibition, while no difference in all\u2011cause mortality was observed between treatment and placebo groups in ZEUS.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        Will the ZEUS trial outcome impact Novo Nordisk\u2019s 2026 financial outlook for NVO shareholders?<\/p>\n<p>&#13;<br \/>\n          The ZEUS outcome will not change Novo Nordisk\u2019s previously communicated adjusted operating profit outlook for 2026. According to Novo Nordisk, the result will, however, lead to a non\u2011cash impairment charge in the third quarter of 2026 related to the ziltivekimab programme.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        What are the next steps for ziltivekimab after the ZEUS trial results at Novo Nordisk (NVO)?<\/p>\n<p>&#13;<br \/>\n          Novo Nordisk will continue two other cardiovascular outcomes trials with ziltivekimab, HERMES and ARTEMIS. According to Novo Nordisk, HERMES studies heart failure and ARTEMIS studies post\u2011acute heart attack, with both trials expected to read out in the first half of 2027.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        What is the design and patient population of the ZEUS cardiovascular outcomes trial for Novo Nordisk\u2019s ziltivekimab?<\/p>\n<p>&#13;<br \/>\n          ZEUS is a double\u2011blind, placebo\u2011controlled, event\u2011driven phase 3 trial evaluating monthly subcutaneous ziltivekimab 15 mg. According to Novo Nordisk, it enrolled over 6,300 people with ASCVD, CKD and cardiovascular inflammation defined by hsCRP \u22652 mg\/L, on top of standard of care therapy.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        How did ziltivekimab affect inflammatory biomarkers like IL-6 and hsCRP in Novo Nordisk\u2019s ZEUS trial?<\/p>\n<p>&#13;<br \/>\n          Ziltivekimab achieved target engagement and IL\u20116 pathway inhibition, with expected reductions in free IL\u20116 and hsCRP. According to Novo Nordisk, these biomarker improvements did not translate into fewer MACE events versus placebo in people with ASCVD, CKD and elevated hsCRP in ZEUS.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n&#13;<\/p>\n","protected":false},"excerpt":{"rendered":"&#13; &#13; &#13; Novo Nordisk (NYSE:NVO) reported headline results from the phase 3 ZEUS cardiovascular outcomes trial of&hellip;\n","protected":false},"author":2,"featured_media":138537,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[66764,48475,66869,66868,272,3859,66804,66805],"class_list":["post-138536","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-cardiovascular-outcomes","tag-chronic-kidney-disease","tag-il-6","tag-major-adverse-cardiovascular-events","tag-novo-nordisk","tag-nvo","tag-zeus-trial","tag-ziltivekimab"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/117016843380203444","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/138536","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=138536"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/138536\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/138537"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=138536"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=138536"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=138536"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}