STEP program investigator Robert F. Kushner, MD, reviews the "unprecedented" clinical trial results for semaglutide 2.4 mg and speaks specifically to primary care clinicians treating obesity.
"Each [clinical trial] taught us something about the biology of obesity and what outcomes an effective medication can have on weight loss and on secondary outcomes, ie, cardiovascular risk factors," Dr Robert Kushner told Patient Care Online in a conversation leading in to the first day of the American Diabetes Association 81st Annual Scientific Sessions, June 25-29, 2021.
Kushner, who served as a lead investigator, is referring to the 4 phase 3a randomized clinical trials in the STEP (Semaglutide Treatment Effect in People with obesity) program evaluating the GLP-1 receptor agonist semaglutide 2.4 mg for chronic weight management. Among the most compelling results across the 4 trials was weight loss as high as 20% of initial body weight in some participants.
Semaglutide 2.4 mg was approved in early June by the FDA for chronic weight management in patients with overweight or obesity.
In the interview that follows, Kushner emphasizes the essential clinical question posed and answered by each trial and most importantly how both the question and answer relate to treatment of obesity in the primary care setting. For example, results of the STEP 3 trial which randomized patients treated with semaglutide 2.4 mg to an intensive behavioral therapy intervention, demonstrated only very modest additional weight loss vs the regular care group. Kushner says the findings underscore the "power" of the pharmacotherapy itself against the disease process underlying obesity and suggest that resource-intensive counseling may not be required.
Robert F. Kushner, MD, is Professor of Medicine and Medical Education at the Northwestern University Feinberg School of Medicine and Director of the Center for Lifestyle Medicine in Chicago, IL.