Investigational Dose of Semaglutide Shows 20.7% Weight Loss at 72 Weeks

Patients treated with semaglutide (Ozempic, Wegovy; Novo Nordisk) 7.2 mg showed a superior weight loss of 20.7% after 72 weeks compared with a 17.5% weight loss and 2.4% weight loss with semaglutide 2.4 and the placebo, respectively. The headline results come from the STEP UP study (NCT05646706), which is a phase 3b trial that is part of the STEP program, according to Novo Nordisk.¹

Investigational semaglutide dosage reduces weight loss by 20.7%. | Image Credit: alones | stock.adobe.com

"We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a news release. “Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy, including cardiovascular risk reduction as seen in SELECT.”¹

The aim of the study included determining the weight loss for individuals from the beginning to the end of the study, with some patients taking an investigational dose of semaglutide. Furthermore, investigators of the study talked with participants about lifestyle changes, including healthy food choices and being more physically active. The study medication—either the investigational dose, the lower semaglutide dose, or the placebo—was injected subcutaneously. For the first part of the study, patients received 1 injection once weekly until they reached the planned dose, and the second part included a transition period of 3 injections right after each other once weekly. The trial lasted approximately 72 weeks, followed by a 9-week follow-up without interventions.²

Investigators included 1407 patients who were 18 years and older with a body mass index of 30 kg/m² or greater and at least 1 self-reported unsuccessful dietary effort to lose body weight. Patients were excluded if they had a history of type 1 or type 2 diabetes, received treatment with glucose-lowering medications within 90 days before screening, and a personal or first-degree relative history of multiple endocrine neoplasia type 1 or medullary thyroid cancer, according to the clinical trial information.²

Investigators found that 33.2% of patients who received the investigational dose had 25% or more weight loss after 72 weeks compared with 16.7% and 0% with low dose semaglutide and the placebo, respectively. The investigational dose semaglutide appeared to have a well-tolerated safety profile in line with other glucagon-like peptide-1 receptor agonists. Investigators reported common adverse effects that were gastrointestinal that were mild to moderate in nature and diminished over time.¹

The full data from the STEP Up trial are expected to be presented at a scientific conference in 2025, and the results of the STEP UP T2D trial, including patients with type 2 diabetes and obesity, are expected within the next few months, according to the news release.¹

REFERENCES

1. Semaglutide 7.2 mg dv achieved 20.7% weight loss in the STEP UP obesity trial, and 18.7% regardless of treatment adherence. News release. Novo Nordisk. January 17, 2024. Accessed January 22, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915087

2. A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) (STEP UP). ClinicalTrials.gov ID: NCT05646706. Updated December 12, 2024. Accessed January 22, 2025. https://clinicaltrials.gov/study/NCT05646706