{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T08:13:00Z","timestamp":1791879180810,"version":"4.3.4"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T00:00:00Z","timestamp":1728259200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T00:00:00Z","timestamp":1728259200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"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":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Pharmacotherapeutic options for obesity treatment include glucagon\u2010like peptide\u20101 receptor (GLP\u20101R) agonists, for example, liraglutide. However, an unmet need remains, particularly in patients with a high body mass index (BMI), as GLP\u20101R agonists are associated with gastrointestinal adverse events (AEs) and some patients do not respond to treatment. Neuropeptide Y (NPY) and peptide YY bind G\u2010protein\u2010coupled Y receptors and represent attractive targets for modulating bodyweight.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This first\u2010in\u2010human, three\u2010part, partially blinded phase I study (NCT04903509) investigated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of the peptidic NPY2R agonist BI 1820237, with\/without low\u2010dose liraglutide: part 1 (participants randomized to receive BI 1820237: 0.075\u20132.4\u2009mg or placebo), part 2 (BI 1820237: 1.2\u2009mg or placebo) and part 3 (BI 1820237: 0.025\u20131.2\u2009mg\u2009+\u2009liraglutide 0.6\u2009mg or placebo\u2009+\u2009liraglutide 0.6\u2009mg). Primary endpoint is the proportion of participants with drug\u2010related AEs. Secondary endpoints are tolerability, PK and PD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 95 otherwise healthy men with increased BMI (25.0\u201334.9\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) were randomized. Drug\u2010related AEs, mainly gastrointestinal events, were reported by 39.0% of participants (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200923) in parts 1\u2009+\u20092 and 30.6% of participants (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200911) in part 3; one drug\u2010related AE (11.1%, part 3) was reported in a participant receiving placebo with liraglutide. Post\u2010dose paracetamol PK suggested that BI 1820237 and low\u2010dose liraglutide exhibited additive effects on gastric emptying.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>BI 1820237 treatment was associated with transient nausea and vomiting at higher doses. No differences in tolerability were observed when combined with liraglutide; effects on gastric emptying appeared additive.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15984","type":"journal-article","created":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T07:50:04Z","timestamp":1728287404000},"page":"71-80","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A randomized phase I study of\n                    <scp>BI<\/scp>\n                    1820237, a novel neuropeptide Y receptor type 2 agonist, alone or in combination with low\u2010dose liraglutide in otherwise healthy men with overweight or obesity"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1071-7000","authenticated-orcid":false,"given":"Nadine","family":"Beetz","sequence":"first","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Biberach an der Ri\u00df Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigitte","family":"Kalsch","sequence":"additional","affiliation":[{"name":"CRS Clinical Research Services Mannheim GmbH  Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2132-5691","authenticated-orcid":false,"given":"Thomas","family":"Forst","sequence":"additional","affiliation":[{"name":"CRS Clinical Research Services Mannheim GmbH  Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-4516-3467","authenticated-orcid":false,"given":"Bernhard","family":"Schmid","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. KG  Biberach an der Ri\u00df Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armin","family":"Schultz","sequence":"additional","affiliation":[{"name":"CRS Clinical Research Services Mannheim GmbH  Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5149-4966","authenticated-orcid":false,"given":"Anita M.","family":"Hennige","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Biberach an der Ri\u00df Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,7]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(14)60892\u20108"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/obr.12551"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003198"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(18)32203\u20107"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13098\u2010020\u201000570\u2010y"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP161365.GL"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.37765\/ajmc.2022.89292"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.15796"},{"key":"e_1_2_11_10_1","unstructured":"Novo Nordisk A\/S.Liraglutide (Saxenda). 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