Novo Nordisk’s oral therapy Wegovy (semaglutide) reduced cardiovascular risk factors in the Phase III OASIS 4 trial.
Being used by the company to support the drug’s approval in obesity, the study led to greater improvements in risk factors such as C-reactive protein and serum triglycerides.
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It also improved blood sugar control in patients, reducing glycaemic parameters, including HbA1c, fasting plasma glucose, and fasting serum insulin.
Presented at Obesity Week 2025 in Atlanta, Georgia, the data showed that in the overall trial population, 71.1% of patients treated with oral Wegovy who had pre-diabetes at trial initiation achieved normal blood glucose at week 64 compared with 33.3% in the placebo cohort.
In Wegovy patients who achieved a greater than 15% body weight reduction, there was a 10.1mmHg reduction in systolic and a 4.3mmHg reduction in diastolic compared with 4.1mmHg, as well as 1.1mmHg reductions in systolic and diastolic readings in patients who achieved less than 15% weight loss.
There were also notable reductions in inflammatory marker C-reactive protein, lipids including non–high density lipoprotein cholesterol, and triglycerides, suggesting improvements in overall health beyond weight loss.
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By GlobalDataWashington Center for Weight Management and Research director and trial investigator Dr Domenica Rubino said: “It’s exciting to see these new results from the cardiometabolic post hoc analysis, which showed that while benefits were most pronounced in people who achieved greater than 15% weight loss, clear improvements in glycaemic parameters and cardiovascular risk factors were observed in patients taking oral Wegovy, regardless of how much weight was lost, based on the groups observed.”
Novo Nordisk eyeing larger slice of obesity pie
Dosed at 25mg, oral Wegovy is currently under review by the US Food and Drug Administration (FDA) for approval for use as a treatment for obesity. There is an oral version of semaglutide already approved in type 2 diabetes (T2D), which is marketed as Rybelsus and begins as a 3mg dose of the drug, before patients advance to 7mg and finally increased to a 14mg maintenance dose.
Novo Nordisk will be hoping to gain approval of the drug in obesity from the FDA before its main competitor, Eli Lilly, secure approval for its own oral candidate, orforglipron. This outcome is likely given that Novo Nordisk submitted its approval to the agency before Eli Lilly.
In spite of this, Novo Nordisk is still protecting its status in the obesity and T2D space as it is in the throes of a bidding war with Pfizer for biotech Metsera, a move that Pfizer deems illegal. If successful, this would add more injectable and oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidates to its portfolio.
This all comes at a time when Eli Lilly seems to be winning in the metabolic race, with Q3 sales jumping for the company’s GLP-1RA tirzepatide, marketed as Mounjaro and Zepbound in T2D and obesity, respectively. Mounjaro generated sales of $6.5bn in Q3 2025, up 109% from the same period in 2024. Zepbound exhibited an even higher growth of 185% on Q3 2024, generating $3.6bn.
Meanwhile, Novo Nordisk has reduced its sales growth to 8% to 11% at constant exchange rates (CER), compared to a previous forecast of 8% to 14%, partially due to slowing sales of Ozempic and Wegovy.
This comes as pharma and biotechs across the globe are trying to work their way into the lucrative obesity market, which GlobalData forecasts will generate $173.5bn in 2031 across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US).
GlobalData is the parent company of Clinical Trials Arena.
