CHAPEL HILL, N.C. - Christian Hendershot, PhD, associate professor of psychiatry and director of the Clinical and Translational Addiction Research Program at the UNC School of Medicine, recently presented early findings from the first completed randomized controlled trial of semaglutide in participants with alcohol use disorder (AUD).
The preliminary and unpublished findings, which were presented at the Research Society on Alcohol's Annual Meeting, showed a reduction in heavy drinking and drinking quantity among those who were given semaglutide versus the placebo group.
"We believe these findings are promising and warrant further trials of GLP-1 receptor agonists in treatment-seeking participants with alcohol use disorder," said Hendershot, who is also a member of the Bowles Center for Alcohols Studies at the UNC School of Medicine.
Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA) was originally formulated to treat diabetes and has emerged as a weight loss drug. Anecdotal observations from patients have suggested the drug may also reduce alcohol and other substance cravings. This possibility is also consistent with numerous preclinical studies over the past decade, which led Hendershot and other groups to design early randomized clinical trials of GLP-1RAs in participants with AUD.
Participants in the Phase II randomized controlled trial were non-treatment-seeking volunteers who reported symptoms of alcohol use disorder. A total of 48 participants were randomized to medication or placebo groups. Participants assigned to the medication arm received the lower two clinical doses of semaglutide (0.25mg/week, 0.5mg/week) over approximately 2 months. The study was funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Preliminary results from the trial indicate that those taking the medication experienced greater reductions in drinking quantity and heavy drinking more than those in the placebo group. Given the magnitude of the effects at relatively lower doses, it appears that semaglutide could have the potential to reduce drinking to a greater extent than existing medications. With 96% of those in the medication group finishing the study, researchers concluded that the drug was safe and well tolerated in this population.
Replication studies will be needed to further confirm the safety, tolerability, and efficacy of semaglutide at higher doses in this population, and to identify patient subgroups that are more or less responsive to GLP-1RAs.
Other UNC-based co-investigators on the study include Klara Klein, MD, PhD, assistant professor at the Department of Medicine's Division of Endocrinology and Metabolism; Amanda Tow, MD, PhD, assistant professor in the Department of Psychiatry; and Robyn Jordan, MD, PhD, associate professor in the Department of Psychiatry and medical director of the UNC Addiction Medicine Program.
