The University of Alabama at Birmingham,UAB, announced Monday that an oral formulation of semaglutide has received United States Food and Drug Administration approval for a new drug or biologic under the Prescription Drug User Fee Act.
The University served as one of the clinical trial sites, led by W. Timothy Garvey, M.D., professor in the UAB School of Health Professions.
Researchers found that oral semaglutide is nearly as effective as the widely used injectable version for treating obesity, delivering about 13.7 percent average weight loss over 64 weeks. The Phase 3 OASIS-4 trial compared a 25 mg once-daily pill to placebo alongside lifestyle counseling and showed significant improvements in blood pressure, cholesterol, blood sugar and inflammation.
Side effects, primarily gastrointestinal, were consistent with other GLP-1 medications and led to discontinuation in only about 5 percent of participants.
“The oral option could improve long-term adherence by offering patients a non-injectable alternative with similar metabolic benefits,” Garvey said. “We need ways to keep patients on these medicines long term, and an effective oral preparation could help us do that.”
At UAB, Garvey holds the C. E. Butterworth Endowed Professorship in the Department of Nutrition Sciences and is a University Professor in the School of Health Professions.
Funding for the OASIS-4 clinical trial was provided by Novo Nordisk.
