Mataki na 2 Gwajin Clinical na Retatrutide, Mai karɓar Hormone-Mai karɓar Agonist sau uku, don Maganin Kiba

Fage da Nazari Design

Retatrutide (LY3437943) sabon magani ne mai peptide guda ɗaya wanda ke kunnawa.uku masu karɓa lokaci gudaGIP, GLP-1, da glucagon. Don kimanta ingancin sa da amincin sa a cikin mutane masu kiba amma ba tare da ciwon sukari ba, an gudanar da wani lokaci na 2, bazuwar, makafi biyu, gwajin sarrafa wuribo (NCT04881760). Jimlar338 mahalartatare da BMI ≥30, ko ≥27 tare da aƙalla nau'i mai alaƙa da haɗin gwiwa, an bazu don karɓar placebo ko retatrutide (1 MG, 4 MG tare da jadawalin titration guda biyu, 8 MG tare da jadawalin titration guda biyu, ko 12 MG) ana gudanar da shi sau ɗaya kowane mako ta allurar subcutaneous don makonni 48. Thefarkon ƙarshen ƙarshenshine canjin kashi a cikin nauyin jiki a makonni 24, tare da ƙarshen ƙarshen biyu ciki har da canjin nauyi a makonni 48 da ƙimar asarar nauyi (≥5%, ≥10%, ≥15%).

Mabuɗin Sakamako

• sati 24: Mafi ƙanƙanta-squares yana nufin canjin kashi cikin nauyin jiki dangane da tushe ya kasance

  • Matsayi: -1.6%

  • 1 MG: -7.2%

  • 4 MG (haɗe): -12.9%

  • 8 MG (haɗe): -17.3%

  • 12 MG: -17.5%

• sati 48: Canjin kashi kashi cikin nauyin jiki ya kasance

  • Matsayi: -2.1%

  • 1 mg: -8.7%

  • 4 MG (haɗe): -17.1%

  • 8 MG (haɗe): -22.8%

  • 12 MG: -24.2%

A makonni 48, adadin mahalarta da suka cimma maƙasudin asarar nauyi na asibiti suna da ban mamaki:

• ≥5% asarar nauyi: 27% tare da placebo vs. 92-100% a cikin ƙungiyoyi masu aiki

• ≥10%: 9% tare da placebo vs. 73-93% a cikin ƙungiyoyi masu aiki

• ≥15%: 2% tare da placebo vs. 55-83% a cikin ƙungiyoyi masu aiki

A cikin rukunin 12 MG, har zuwa26% na mahalarta sun rasa ≥30% na nauyin asali, Girman asarar nauyi kwatankwacin tiyatar bariatric.

Tsaro
Mafi yawan abubuwan da suka fi dacewa sun hada da gastrointestinal (tashin zuciya, amai, gudawa), gabaɗaya mai sauƙi zuwa matsakaici da alaƙa da kashi. Ƙananan fara allurai (2 MG titration) ya rage waɗannan abubuwan. An lura da haɓakar adadin da ke da alaƙa a cikin bugun zuciya, yana ƙaruwa a mako 24, sannan raguwa. Yawan katsewa ya tashi daga 6-16% a cikin ƙungiyoyi masu aiki, da ɗan sama da placebo.

Ƙarshe
A cikin manya masu fama da kiba ba tare da ciwon sukari ba, ana samar da retatrutide na subcutaneous mako-mako na makonni 48ƙwaƙƙwaran, raguwa-dogara a cikin nauyin jiki(har zuwa ~ 24% yana nufin hasara a mafi girman kashi), tare da ingantawa a cikin alamun cardiometabolic. Abubuwan da ke faruwa a cikin hanji sun kasance akai-akai amma ana iya sarrafa su tare da titration. Waɗannan binciken na lokaci na 2 suna ba da shawarar retatrutide na iya wakiltar sabon ma'aunin warkewa don kiba, yana jiran tabbatarwa a cikin mafi girma, gwaji na lokaci mai tsawo.