Novo Nordisk Announces Results From STEP 5 Trial for Semaglutide

Novo Nordisk has announced the results from the STEP 5 phase 3b trial showing that individuals treated with semaglutide (Wegovy) injection at the 2.4-mg dosage achieved significant and sustained weight loss over the 2-year study period.

"Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight while taking Wegovy and maintain the weight loss at 2 years, which can help us better treat and manage obesity as a chronic disease," Timothy Garvey, MD, professor of medicine for the department of nutrition sciences at the University of Alabama in Birmingham, said in a statement.

In the STEP 5 trial, results show that semaglutide significantly reduced body weight from baseline to week 104 compared with the placebo. Individuals who were obese or overweight were more likely to lose at least 5% of their body weight with the medication than those who took the placebo.

Individuals were split into 2 groups: 1 taking the placebo and 1 taking semaglutide. Both groups also increased physical activity and reduced their caloric intake. There were 304 individuals in the study during a 104-week period.

Previously, 68-week trials showed that the most frequently reported adverse events were abdominal pain, constipation, diarrhea, nausea, and vomiting.

In the STEP 5 trial, the safety profile was in line with the previous STEP phase 3a trial.

The results were presented at the ObesityWeek 2021 interactive congress.

Reference

Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity. Novo Nordisk. News release. November 5, 2021. Accessed November 15, 2021. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=85378