FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4308133715> ?p ?o ?g. }

• W4308133715 endingPage "A409" @default.
• W4308133715 startingPage "A409" @default.
• W4308133715 abstract "Abstract HM15136 is a novel long-acting glucagon analogue with an extended half-life. In vivo efficacy studies of HM15136 in animal models showed its therapeutic potential in obesity, and treatment requiring hypoglycemia. We enrolled an obese and overweight subjects without diabetes (study Part 1) and with diabetes (study Part 2) in a randomized, double-blind, placebo-controlled study to assess the safety, pharmacokinetics, and pharmacodynamics of multiple subcutaneous doses of HM15136 for 12 weeks (NCT04167553). In Part 1, a total of 36 non-diabetic subjects randomly received HM15136 or its matching placebo in a ratio of 9: 3 in 3 cohorts (0.02, 0.04, and 0.06 mg/kg). The baseline mean age was 37.5 years, BMI was 33.9 kg/m2, and Fasting Plasma Glucose (FPG) was 92.3 mg/dL. The FPG increased with escalating doses of HM15136. The mean (SD) changes from baseline in FPG at week 12 were -1.0 (13.0) mg/dL for 0.02 mg/kg, 12.0 (10.7) mg/dL for 0.04 mg/kg, 17.9 (16.9) mg/dL for 0.06 mg/kg vs. 0.6 (6.5) mg/dL for placebo group. The FPG had returned to baseline at 3 weeks after study drug discontinuation. The presence of Anti-Drug Antibodies (ADAs) was confirmed in 5 subjects (18.5%) but dose-dependency was not observed. One (1) out of 5 ADA positive subjects had neutralizing ADA activity with no cross reactivity to endogenous glucagon. The most frequent Treatment Related Adverse Event (TRAE) was injection site erythema (11.1%), the frequency of TRAEs was not dose dependent. Throughout Part 1 and Part 2, all TRAEs were mild except for moderate hyperglycemia in patients with diabetes. Part 2 was completed earlier than planned due to the impact of COVID-19 and discontinued subjects due to the hyperglycemia. Part 2 was not included in this presentation because the interpretability of the data was limited. In conclusion, HM15136 was safe and well tolerated in non-diabetic obese subjects during the 12-week treatment at various dose levels. Treatment with HM15136 showed a dose dependent blood glucose increase. These results suggest future development opportunities for the management of treatment requiring hypoglycemia. A phase 2, Proof-of-Concept study in patients with congenital hyperinsulinism is currently ongoing (NCT04732416). Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m." @default.
• W4308133715 created "2022-11-08" @default.
• W4308133715 creator A5022251874 @default.
• W4308133715 creator A5034282455 @default.
• W4308133715 creator A5043015378 @default.
• W4308133715 creator A5044166679 @default.
• W4308133715 creator A5046994140 @default.
• W4308133715 creator A5053897485 @default.
• W4308133715 creator A5074442084 @default.
• W4308133715 date "2022-11-01" @default.
• W4308133715 modified "2023-09-26" @default.
• W4308133715 title "PSUN305 A Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Obese or Overweight Subjects with Co-morbidities" @default.
• W4308133715 doi "https://doi.org/10.1210/jendso/bvac150.851" @default.
• W4308133715 hasPublicationYear "2022" @default.
• W4308133715 type Work @default.
• W4308133715 citedByCount "0" @default.
• W4308133715 crossrefType "journal-article" @default.
• W4308133715 hasAuthorship W4308133715A5022251874 @default.
• W4308133715 hasAuthorship W4308133715A5034282455 @default.
• W4308133715 hasAuthorship W4308133715A5043015378 @default.
• W4308133715 hasAuthorship W4308133715A5044166679 @default.
• W4308133715 hasAuthorship W4308133715A5046994140 @default.
• W4308133715 hasAuthorship W4308133715A5053897485 @default.
• W4308133715 hasAuthorship W4308133715A5074442084 @default.
• W4308133715 hasBestOaLocation W43081337151 @default.
• W4308133715 hasConcept C111113717 @default.
• W4308133715 hasConcept C112705442 @default.
• W4308133715 hasConcept C126322002 @default.
• W4308133715 hasConcept C134018914 @default.
• W4308133715 hasConcept C142724271 @default.
• W4308133715 hasConcept C197934379 @default.
• W4308133715 hasConcept C204787440 @default.
• W4308133715 hasConcept C27081682 @default.
• W4308133715 hasConcept C2778375690 @default.
• W4308133715 hasConcept C2778715236 @default.
• W4308133715 hasConcept C2780586474 @default.
• W4308133715 hasConcept C2780668416 @default.
• W4308133715 hasConcept C511355011 @default.
• W4308133715 hasConcept C555293320 @default.
• W4308133715 hasConcept C71924100 @default.
• W4308133715 hasConcept C90924648 @default.
• W4308133715 hasConcept C98274493 @default.
• W4308133715 hasConceptScore W4308133715C111113717 @default.
• W4308133715 hasConceptScore W4308133715C112705442 @default.
• W4308133715 hasConceptScore W4308133715C126322002 @default.
• W4308133715 hasConceptScore W4308133715C134018914 @default.
• W4308133715 hasConceptScore W4308133715C142724271 @default.
• W4308133715 hasConceptScore W4308133715C197934379 @default.
• W4308133715 hasConceptScore W4308133715C204787440 @default.
• W4308133715 hasConceptScore W4308133715C27081682 @default.
• W4308133715 hasConceptScore W4308133715C2778375690 @default.
• W4308133715 hasConceptScore W4308133715C2778715236 @default.
• W4308133715 hasConceptScore W4308133715C2780586474 @default.
• W4308133715 hasConceptScore W4308133715C2780668416 @default.
• W4308133715 hasConceptScore W4308133715C511355011 @default.
• W4308133715 hasConceptScore W4308133715C555293320 @default.
• W4308133715 hasConceptScore W4308133715C71924100 @default.
• W4308133715 hasConceptScore W4308133715C90924648 @default.
• W4308133715 hasConceptScore W4308133715C98274493 @default.
• W4308133715 hasIssue "Supplement_1" @default.
• W4308133715 hasLocation W43081337151 @default.
• W4308133715 hasLocation W43081337152 @default.
• W4308133715 hasOpenAccess W4308133715 @default.
• W4308133715 hasPrimaryLocation W43081337151 @default.
• W4308133715 hasRelatedWork W137885780 @default.
• W4308133715 hasRelatedWork W2028648326 @default.
• W4308133715 hasRelatedWork W2112620969 @default.
• W4308133715 hasRelatedWork W2122556001 @default.
• W4308133715 hasRelatedWork W2328878243 @default.
• W4308133715 hasRelatedWork W2626992247 @default.
• W4308133715 hasRelatedWork W2922882148 @default.
• W4308133715 hasRelatedWork W3023502736 @default.
• W4308133715 hasRelatedWork W3159937175 @default.
• W4308133715 hasRelatedWork W4319063555 @default.
• W4308133715 hasVolume "6" @default.
• W4308133715 isParatext "false" @default.
• W4308133715 isRetracted "false" @default.
• W4308133715 workType "article" @default.