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This phase 2 trial involving patients with NASH showed that treatment with semaglutide resulted in a significantly higher percentage of patients with … Sponsor staff involved in the clinical trial is masked according to company standard procedures. The drug was discovered and developed by Novo Nordisk, which submitted a new drug application (NDA) for the drug to the US Food and Drug Administration (FDA) under the Prescription Drug User Fee Act V (PDUFA V) regulation in December 2016. The Semaglutide Treatment Effect in People with obesity (STEP trials 1‐5) clinical development program is one of the largest clinical trial programs for the management of obesity and assessed the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Novo Nordisk A/S, Denmark. Aroda VR, Bain SC, Cariou B, et al. The dual GIP/GLP-1 agonist beat Novo Nordisk’s semaglutide … About the STEP clinical programme STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development programme with once-weekly subcutaneous semaglutide … The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. Ozempic ® (semaglutide) is a glucagon-like peptide (GLP-1) receptor agonist indicated for the treatment of Type 2 diabetes in adults.. It is considered an investigational drug in this study for two reasons: 1. Another phase 3 clinical trial of Eli Lilly’s tirzepatide in Type 2 diabetics has met its primary endpoint. Lancet Diabetes Endocrinol. The dose of semaglutide being used in the study is higher than the dose currently used in … PIONEER 1 (NCT02906930) evaluated oral semaglutide in 703 drug-naïve patients with T2D who were not controlled on diet and exercise. In a clinical trial, participants taking semaglutide lost 15 percent of their body weight, on average. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naïve patients with type 2 diabetes (SUSTAIN 4): a randomized, open-label, parallel-group, multicenter, multinational, phase 3a trial. The PIONEER clinical trials for oral semaglutide is a global development program that has enrolled 8,845 people with T2D across 10 clinical trials. Which treatment the participants get is decided by chance. Novo Nordisk’s semaglutide injection effective in weight loss trial. Novo Nordisk A/S, Denmark. Semaglutide is a medicine doctors prescribe in some countries (including the United States) to treat Type 2 Diabetes. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.