NgoJulayi 27, 2023, uLilly wamemezela ukuthi ucwaningo lwe-Mount-3 lwe-Tirzepatide lokwelapha iziguli ezikhuluphele kanye nocwaningo lwe-Mount-4 lokugcina ukwehla kwesisindo seziguli ezikhuluphele lufinyelele ekugcineni kanye nendawo yokugcina ebalulekile.Lolu wucwaningo lwesigaba III oluyimpumelelo lwesigaba III olutholwe yi-Tirzepatide ngemva kwe-Mount-1 ne-Mount-2.
I-SURMOUNT-3 (NCT04657016) iyisivivinyo esilawulwa yi-multicenter, esingahleliwe, esingaboni kabili, esihambisanayo, esilawulwa yi-placebo esibhalisa ingqikithi yabahlanganyeli abangu-806 eklanyelwe ukubonisa ukuphakama kwe-Tirzepatide kune-placebo mayelana noshintsho lwephesenti ekushintsheni kwesisindo ngemva kokungahleliwe kanye namaphesenti ababambiqhaza abalahlekelwe ≥5% ngemuva kokungahleliwe emavikini angama-72.
Imiphumela yocwaningo lwe-SURMOUNT-3 ibonise ukuthi i-Tirzepatide ihlangabezane nazo zonke iziphetho, okungukuthi ngemva kwamasonto angu-72 okwelashwa kwe-dosing, iziguli eziseqenjini le-Tirzepatide zithole amaphesenti aphezulu okuncipha kwesisindo kusukela kwesisekelo uma kuqhathaniswa ne-placebo, kanye namaphesenti aphezulu eziguli eqenjini le-Tirzepatide. uthole ukwehla kwesisindo esingamaphesenti angaphezu kuka-5%.Idatha ethile yomtholampilo ibonise ukuthi iziguli eziphathwe nge-Tirzepatide zilahlekelwe isilinganiso se-21.1% yesisindo somzimba uma kuqhathaniswa ne-placebo;Kuhlanganiswe nesikhathi sokungenelela samasonto ayi-12, iziguli eziphathwe nge-Tirzepatide zilahlekelwe isilinganiso samaphesenti angama-26.6 wesisindo somzimba wazo.Ngaphezu kwalokho, u-94.4% weziguli ulahlekelwe ngu-≥5% wesisindo sazo eqenjini le-Tirzepatide, uma kuqhathaniswa no-10.7% eqenjini le-placebo.
I-SURMOUNT-4 (NCT04660643) iyisivivinyo esilawulwa yi-multicenter, esingahleliwe, esingaboni kabili, esihambisanayo, esilawulwa yi-placebo esibhalisa ingqikithi yabahlanganyeli abangu-783 eklanyelwe ukubonisa ukuthi i-Tirzepatide yayingcono kune-placebo ekushintsheni kwesisindo ngamaphesenti angu-88-isonto le-randomization.
Imiphumela yabonisa ukuthi ngemva kwesikhathi esiyimpumputhe esiphindwe kabili samaviki angu-37–88, iziguli eziseqenjini le-Tirzepatide zalahlekelwa isisindo esingaphezu kweqembu le-placebo.Mayelana nokuphepha, akukho cwaningo lwe-SURMOUNT-3 noma SURMOUNT-4 olubone amasiginali amasha okuphepha.
Kusukela kwethulwa i-Novo Nordisk's blockbuster diet drug Semaglutide, ehambisana nokugunyazwa okuqinile kukaMusk, isibe umkhiqizo osaziwayo we-inthanethi omangalisayo kanye nenkosi yamanje yokulahlekelwa isisindo.Isidingo semakethe yokuncipha kwesisindo sikhulu, futhi kunezidakamizwa ezimbili kuphela ze-GLP-1 ezithengiswayo njengamanje emakethe, i-Liraglutide ne-Semaglutide, kepha i-Liraglutide iyilungiselelo elisebenza isikhathi esifushane, elingakwazi ukuncintisana namalungiselelo athatha isikhathi eside ngokuya ngokuhambisana nesiguli. , futhi umhlaba wamanje wokulahlekelwa isisindo okwesikhashana ungowe-Semaglutide.
Futhi inkosi yenkundla ye-GLP-1, uLilly ufisa ulwandle oluluhlaza okwesibhakabhaka lwemakethe yokuncipha kwesisindo - ngakho-ke uLilly wethula inselelo futhi waqala ukubheja ku-Tirzepatide ukuze abambe indawo emakethe yokuncipha kwesisindo.
I-Tirzepatide iyi-agonist ekabili ye-GIPR/GLP-1R yamasonto onke, i-GIP (i-insulin ethembele ku-glucose evuselela i-polypeptide) ingelinye ilungu lomndeni we-glucagon peptide, elinomphumela wokugqugquzela ukukhiqizwa kwe-insulin ngendlela encike ku-insulin futhi evuselela ukukhiqizwa kweglucagon ku-hypoglycemic. isimo, i-GIPR/GLP-1R i-agonist ekabili ingakhiqiza ukulawula ushukela wegazi, ukuncipha kwesisindo kanye neminye imiphumela ngokuvuselela izindlela zombili ze-GIP ne-GLP-1 ezansi nomfula.I-Tirzepatide igunyazwe yi-FDA ngo-2022-5 (igama lokuhweba: Mounjaro) ukuze isetshenziswe ngokuhambisana nokudla nokuzivocavoca ukuze kuthuthukiswe ukulawulwa kwe-glycemic kubantu abadala abanesifo sikashukela sohlobo 2.
Isikhathi sokuthumela: Sep-18-2023