[{"orgOrder":0,"company":"Novo Nordisk","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novo Nordisk\u2019s First Semaglutide Obesity Trial Hits The Mark","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Novo Nordisk"},{"orgOrder":0,"company":"Novo Nordisk","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novo Nordisk Reports Weight Loss of 14.9% (16.9% if taken as intended) in STEP 1 trial","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Peptide","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Peptide","graph2":"Novo 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Adlumiz (anamorelin) is a selective, novel, orally active ghrelin receptor agonist. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism.
IBI362 (also known as mazdutide), a GLP-1R and GCGR dual agonist, is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM) with a fatty acid side chain attached thereto.
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Tirzepatide is a single novel molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.
Mounjaro (tirzepatide) met both co-primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo for both estimands.
Based on the results, the pharmacology of LY3298176 (tirzepatide) translates from preclinical to clinical studies. LY3298176 has the potential to deliver clinically meaningful improvement in glycaemic control and body weight.
For efficacy estimand, participants taking tirzepatide achieved average weight reduction of 16.0%, 21.4%, and 22.5%, compared to placebo. Additionally, 89% and 96% of people taking tirzepatide achieved at least 5% body weight reductions compared to 28% of those taking placebo.
The global 68-week trial is planned for initiation in the second half of 2021 and will investigate the efficacy and safety of oral semaglutide compared to placebo.
The recent STEP 1 trial showing the beneficial impact of diabetes drug semaglutide on weight could be a game-changer in helping many people with obesity to lose a significant amount of weight.
Northwestern University Feinberg School of Medicine in the US has reported that results from STEP 1 clinical trial of type-2 diabetes drug semaglutide (Ozempic) once weekly was linked to a sustained, clinically relevant reduction in body weight in obese adult participants.
The submission is based on the results from the STEP phase 3a clinical trial programme. Across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo.
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