{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T20:36:32Z","timestamp":1791578192248,"version":"4.3.4"},"reference-count":31,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,3,18]],"date-time":"2024-03-18T00:00:00Z","timestamp":1710720000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>This Phase I study evaluated the safety and early efficacy of an aldosterone synthase inhibitor (BI 690517) in people with diabetes and albuminuric chronic kidney disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Double\u2010blind, placebo\u2010controlled study (NCT03165240) at 40 sites across Europe. Eligible participants [estimated glomerular filtration rate \u226520 and &lt;75\u2009ml\/min\/1.73\u2009m\n                      <jats:sup>2<\/jats:sup>\n                      ; urine albumin\/creatinine ratio (UACR) \u2265200 and &lt;3500\u2009mg\/g] were randomized 6:1 to receive once\u2010daily oral BI 690517 3, 10 or 40\u2009mg, or eplerenone 25\u201050\u2009mg, or placebo, for 28\u2009days. The primary endpoint was the proportion of participants with drug\u2010related adverse events (AEs). Secondary endpoints included changes from baseline in the UACR.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Fifty\u2010eight participants were randomized and treated from 27 November 2017 to 16 April 2020 (BI 690517: 3\u2009mg, n\u2009=\u200918; 10\u2009mg, n\u2009=\u200913; 40\u2009mg, n\u2009=\u200914; eplerenone, n\u2009=\u20094; placebo, n\u2009=\u20099) for 28\u2009days. Eight (13.8%) participants experienced drug\u2010related AEs [BI 690517: 3\u2009mg (two of 18); 10\u2009mg (four of 13); 40\u2009mg (two of 14)], most frequently constipation [10\u2009mg (one of 13); 40\u2009mg (one of 14)] and hyperkalaemia [3\u2009mg (one of 18); 10\u2009mg (one of 13)]. Most AEs were mild to moderate; one participant experienced severe hyperkalaemia (serum potassium 6.9\u2009mmol\/L; BI 690517 10\u2009mg). UACR responses [\u226520% decrease from baseline (first morning void urine) after 28\u2009days] were observed for 80.0% receiving BI 690517 40\u2009mg (eight of 10) versus 37.5% receiving placebo (three of eight). Aldosterone levels were suppressed by BI 690517, but not eplerenone or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>BI 690517 was generally well tolerated, reduced plasma aldosterone and may decrease albuminuria in participants with diabetes and albuminuric chronic kidney disease.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15518","type":"journal-article","created":{"date-parts":[[2024,3,18]],"date-time":"2024-03-18T05:08:29Z","timestamp":1710738509000},"page":"2128-2138","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Aldosterone synthase inhibitor (\n                    <scp>BI<\/scp>\n                    690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double\u2010blind, placebo\u2010controlled, Phase I trial"],"prefix":"10.1111","volume":"26","author":[{"given":"Stefan R.","family":"Bornstein","sequence":"first","affiliation":[{"name":"Universit\u00e4tsklinikum Carl Gustav Carus Dresden  Dresden Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3434-7777","authenticated-orcid":false,"given":"Dick","family":"de Zeeuw","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology University of Groningen University Medical Center Groningen  Groningen Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3126-3730","authenticated-orcid":false,"given":"Hiddo J. L.","family":"Heerspink","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology University of Groningen University Medical Center Groningen  Groningen Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0277-8134","authenticated-orcid":false,"given":"Friedrich","family":"Schulze","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Ingelheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Cronin","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals Inc.  Ridgefield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arne","family":"Wenz","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Biberach Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2235-0103","authenticated-orcid":false,"given":"Katherine R.","family":"Tuttle","sequence":"additional","affiliation":[{"name":"Providence Health Care University of Washington  Spokane Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7110-6994","authenticated-orcid":false,"given":"Samy","family":"Hadjadj","sequence":"additional","affiliation":[{"name":"Nantes Universit\u00e9, CHU Nantes, CNRS, INSERM, l'institut du thorax  Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1531-4294","authenticated-orcid":false,"given":"Peter","family":"Rossing","sequence":"additional","affiliation":[{"name":"Steno Diabetes Center Copenhagen  Copenhagen 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