Full metadata record
DC Field | Value | Language |
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dc.citation.endPage | 2733 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 2723 | - |
dc.citation.title | DIABETES OBESITY & METABOLISM | - |
dc.citation.volume | 25 | - |
dc.contributor.author | Shin, Wonjung | - |
dc.contributor.author | Hompesch, Marcus | - |
dc.contributor.author | Byeon, JinHee | - |
dc.contributor.author | Kang, Seohyun | - |
dc.contributor.author | Choi, Jaehyuk | - |
dc.contributor.author | Baek, Seungjae | - |
dc.date.accessioned | 2023-12-21T12:37:03Z | - |
dc.date.available | 2023-12-21T12:37:03Z | - |
dc.date.created | 2023-07-07 | - |
dc.date.issued | 2023-06 | - |
dc.description.abstract | Aim To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long-acting glucagon analogue HM15136 in overweight/obese patients with co-morbidities, with and without type 2 diabetes (T2D).Materials and Methods This was a phase 1, double-blind, randomized, placebo-controlled, two-part trial with a 12-week treatment period of once-weekly subcutaneous HM15136 (0.02/0.04/0.06 mg/kg). Part 1 included patients with dyslipidaemia and/or hypertension and no T2D. Part 2 included patients with dyslipidaemia and/or hypertension plus T2D.Results In part 1, 23/27 (85.2%) patients receiving HM15136 and all patients receiving placebo (9/9 [100%]) experienced a treatment-emergent adverse event (TEAE). Five of 27 (18.5%) patients receiving HM15136 developed anti-HM15136 antibodies. Dose-dependent increases in mean HM15136 serum concentration and fasting plasma glucose (FPG) were observed, as were dose-dependent weight reductions of 0.5%/2.3%/2.6% at doses of 0.02/0.04/0.06 mg/kg, respectively. In part 2, 8/12 (66.7%) patients receiving HM15136 and all patients receiving placebo (4/4 [100.0%]) reported a TEAE. Two (16.7%) patients developed anti-HM15136 antibodies. Dose-dependent increases in mean HM15136 serum concentration were observed. FPG of more than 200 mg/dL was reported in 4/9 (44.4%) and 2/3 (66.7%) patients receiving 0.02 and 0.06 mg/kg, respectively. The 0.06 mg/kg dose was not tolerated in part 2 because of hyperglycaemia. Patients receiving 0.02 mg/kg showed a 0.9% weight reduction. No serious TEAEs leading to discontinuation were reported in either study part.Conclusions This study of HM15136 provides a preliminary safety and tolerability profile with initial insights into its efficacy profile. | - |
dc.identifier.bibliographicCitation | DIABETES OBESITY & METABOLISM, v.25, no.9, pp.2723 - 2733 | - |
dc.identifier.doi | 10.1111/dom.15162 | - |
dc.identifier.issn | 1462-8902 | - |
dc.identifier.scopusid | 2-s2.0-85163136424 | - |
dc.identifier.uri | https://scholarworks.unist.ac.kr/handle/201301/64787 | - |
dc.identifier.wosid | 001007927700001 | - |
dc.language | 영어 | - |
dc.publisher | WILEY | - |
dc.title | Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long-acting glucagon analogue HM15136 in overweight and obese patients with co-morbidities | - |
dc.type | Article | - |
dc.description.isOpenAccess | TRUE | - |
dc.relation.journalWebOfScienceCategory | Endocrinology & Metabolism | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.type.docType | Article; Early Access | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.subject.keywordAuthor | glucagon | - |
dc.subject.keywordAuthor | hypoglycaemia | - |
dc.subject.keywordAuthor | pharmacodynamics | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordPlus | RECEPTOR | - |
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