Epub 2019 Jun 9. ORLANDO — An oral version of the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic, Novo Nordisk) has shown encouraging results in the first phase 3 …

After 72 weeks of therapy with the highest dosage tested (0.4 mg), 33 of 56 patients (59%) with fibrosis stages F2 to F3 could say that, versus 10 … This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). 1. Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) ... Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3: Study Design. Bagsværd, Denmark, 22 February 2018 - Novo Nordisk today announced the headline results from PIONEER 1, the first phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. 2019 Jul;7(7):515-527. doi: 10.1016/S2213-8587(19)30192-5. Dive Brief: Danish drugmaker Novo Nordisk on Thursday unveiled positive clinical results from two Phase 3 trials of its diabetes drug semaglutide, strengthening its case for the experimental oral version of the glucagon-like peptide (GLP)-1 analogue. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.

Lancet Diabetes Endocrinol. In the phase 2 trial, a significantly higher percentage of patients on daily semaglutide injections saw NASH symptoms resolve—liver inflammation improved and liver cell ballooning eased—and no worsening in liver fibrosis than placebo patients experienced. On Friday, Novo Nordisk announced the results from PIONEER 1, a phase 3a trial featuring oral semaglutide for treatment of adults with type 2 diabetes (T2D). GLP-1 agonist semaglutide is already driving sales growth at Novo Nordisk from its use in diabetes, and now looks like it could add non-alcoholic steatohepatitis (NASH) to its tally. Novo Nordisk’s semaglutide, which could be the first oral alternative to injectable GLP-1 agonists in type 2 diabetes, has started phase III trials. FDA approval of oral semaglutide (Rybelsus) to improve control of blood sugar in adult patients with type 2 diabetes arrived on Sept. 20, 2019. Dive Brief: Weeks after reporting positive Phase 3 results in diabetes patients for oral semaglutide, Novo Nordisk A/S followed up with another set of solid results, this time for the once-daily injectable version in a mid-stage study in obese patients without diabetes. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83).