{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T20:20:26Z","timestamp":1780604426104,"version":"3.54.1"},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T00:00:00Z","timestamp":1754438400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T00:00:00Z","timestamp":1754438400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>GLY\u2010200 is an investigational oral polymeric drug designed to enhance the barrier function of gastrointestinal mucus as a non\u2010invasive alternative to metabolic surgery. This study evaluated the safety, tolerability and pharmacodynamic effects of GLY\u2010200 in patients with T2D.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      This phase 2, placebo (PBO)\u2010controlled, double\u2010blind single\u2010centre inpatient study (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      , NCT05478525) enrolled patients (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200951) aged 30\u201370\u2009years with T2D (HbA1c \u22656.0% to &lt;8.5%) on stable metformin \u2265750\u2009mg\/day for \u22653\u2009months. Patients received 14\u2009days twice a day (BID) of 0.5, 1.0, or 2.0\u2009g GLY\u2010200 or PBO (1:1:1:1). The primary endpoint was safety and tolerability. Additional endpoints included changes in plasma glucose (secondary) and calories and lipid profiles (exploratory).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      GLY\u2010200 appeared safe and well tolerated. The most frequently related TEAEs in subjects treated with GLY\u2010200 were constipation, nausea, diarrhoea and vomiting, all of which were mild. Improvements in fasting and postprandial glucose were observed. For 2.0\u2009g Day 14 postprandial glucose post\u2010standardized meal, mean absolute AUC\n                      <jats:sub>0\u20103HR<\/jats:sub>\n                      difference from PBO was 178.33\u2009mg\/dL*hr (95% CI \u2212327.16 to \u221229.50;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.02);\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      difference was 50.88\u2009mg\/dL (\u2212100.23 to \u22121.54;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.04). Day 14 mean change from baseline fasting serum glucose in the 2.0\u2009g group was \u221216.1 (SD 22.5) versus 12.1 (41.8) mg\/dL in the PBO group. GLY\u2010200 treatment also resulted in numerical reductions in food intake, modest decreases in body weight, and improvements in lipid profiles consistent with a duodenal exclusion mechanism.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results suggest duodenal exclusion is possible with an oral polymeric drug and support further development of GLY\u2010200 for the treatment of T2D and obesity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.16664","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T11:08:36Z","timestamp":1754478516000},"page":"5996-6005","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["<scp>GLY<\/scp>\n                    \u2010200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double\u2010blind placebo\u2010controlled trial"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6147-2157","authenticated-orcid":false,"given":"Christine L. N.","family":"Bryant","sequence":"first","affiliation":[{"name":"Glyscend Therapeutics, Inc  Lowell Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Colbert","sequence":"additional","affiliation":[{"name":"Glyscend Therapeutics, Inc  Lowell Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5867-2131","authenticated-orcid":false,"given":"Marcus","family":"Hompesch","sequence":"additional","affiliation":[{"name":"ProSciento, Inc  Chula Vista California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"SuZanne","family":"Chaves","sequence":"additional","affiliation":[{"name":"ProSciento, Inc  Chula Vista California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Nimgaonkar","sequence":"additional","affiliation":[{"name":"Glyscend Therapeutics, Inc  Lowell Massachusetts USA"},{"name":"Division of Gastroenterology, Department of Medicine Johns Hopkins University  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9883-6847","authenticated-orcid":false,"given":"Mark S.","family":"Fineman","sequence":"additional","affiliation":[{"name":"Glyscend Therapeutics, Inc  Lowell Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,6]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.giec.2016.12.002"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000102989.54824.fc"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000224726.61448.1b"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.soard.2007.02.003"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpendo.00559.2012"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm.2745"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphys.2019.00374"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/en.2011-2145"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-17-0403"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-1985"},{"issue":"11","key":"e_1_2_9_12_1","article-title":"EndoBarrier gastrointestinal liner. 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