When Cheri Ferguson started taking Ozempic last year, she said, she hoped to lose about 50 pounds she’d gained during the Covid-19 pandemic.
But it had another unexpected effect: Ferguson said her desire to drink alcohol and use her vape pen also drained away.
“It’s like someone’s just come along and switched the light on, and you can see the room for what it is,” she said. “And all of these vapes and cigarettes that you’ve had over the years, they don’t look attractive anymore. It’s very, very strange. Very strange.”
It’s a feeling described by thousands of people taking these medicines, which are in a class known as GLP-1 receptor agonists and used by an estimated 15 million Americans, according to a recent poll. And now, Ozempic’s maker, Novo Nordisk, said it intends to study the phenomenon.
The company plans to start assessing the effects of semaglutide, the active ingredient in Ozempic, and other medicines on alcohol consumption this month in a newly announced clinical trial in alcohol-related liver disease – although cutting drinking isn’t the study’s main goal.
A focus on liver disease, not addiction
The Danish drug giant has been saying since at least last year that it doesn’t plan to study semaglutide – which is also approved for weight loss as Wegovy – in areas like alcohol addiction, despite so many anecdotal reports like Ferguson’s, and academic studies that are already underway.
Novo Nordisk reiterated that stance Wednesday, noting that the main purpose of its new trial is to assess whether the medicines can improve liver health. Its primary measure is the medicines’ effects on enhanced liver fibrosis, or scarring, over 28 weeks.
“Secondary endpoints include safety and tolerability and changes in alcohol consumption,” a Novo Nordisk spokesperson said in an email. “There is a significant unmet medical need in alcohol-related liver disease, and the first line of treatment for the condition is lifestyle intervention to refrain from drinking alcohol.”
The trial, first reported by Bloomberg News, aims to enroll about 240 participants and is slated to begin May 20, according to a government database.
“Even though not all patients in the trial will have alcohol use disorder, it is natural to include alcohol consumption as a secondary endpoint,” Novo Nordisk’s spokesperson said, noting that the trial is part of the company’s plans to address liver diseases more broadly.
Nonetheless, researchers in addiction science cheered the news.
A need for more treatments
“Those of us doing work in this area see this as a step in the right direction,” Christian Hendershot, an assistant professor in the Department of Psychiatry and Bowles Center of Alcohol Studies at the University of North Carolina at Chapel Hill, who is running one of the few studies in this area, said by email Wednesday. “Additional treatment options for this group are really needed.”
“We know that one of the benefits in obesity is that it addresses this craving, the desire, to snack and eat,” Lars Fruergaard Jorgensen said. “That function in the brain, in this craving center, is perhaps also what is benefitting some of the other addictions.”
Jorgensen said Novo Nordisk hadn’t studied that effect and had no plans to do so at the time.
“It’s not the easiest to study,” he noted. “You shouldn’t expect that we would go in and study these addictions widely.”
Jorgensen did say there could be “an opportunity to collect data when we do large studies,” as well as to use artificial intelligence to mine large databases of experiences with the medicines in the real world for signals of effects on things like alcohol use.
A spokesperson for Eli Lilly, which makes tirzepatide-based competitors to Ozempic and Wegovy called Mounjaro and Zepbound, said Wednesday that it too had seen “anecdotal commentary in publications about the potential use of GLP-1s for additional indications like addiction.”
But while the Indianapolis-based drugmaker continues “to evaluate future development options for tirzepatide,” the spokesperson said the company hadn’t announced any plans to develop its medicines for those uses.
An unattractive market for drugmakers
Medicines for addiction, and particularly for alcohol use, haven’t been successful financially for the drug industry, leading to less interest from pharmaceutical companies in developing drugs in the space.
Research from financial firm TD Cowen found that less than 5% of the 29 million Americans estimated to have alcohol-use disorder receive drug therapy. The firm pointed to issues like doctors not being familiar with medicines to treat alcohol use and compliance with the drugs.
“It’s very promising and exciting that a company like Novo Nordisk is taking the lead in conducting such an important clinical trial,” Leggio said.
Novo Nordisk is looking at multiple medicines in its newly announced trial in alcohol-related liver disease; in addition to semaglutide, the company said it will investigate experimental drugs cagrilintide and zalfermin – listed on the trial posting as NNC0194-0499 – alone and in combination.
Cagrilintide is a medicine that mimics a hormone called amylin that Novo Nordisk is testing in combination with semaglutide – which mimics another hormone, called GLP-1 – in large trials in both diabetes and weight loss, calling the combination CagriSema. Zalfermin, the company said, acts like yet another metabolic hormone, FGF21, which is produced mainly in the liver.
Though trials in use of semaglutide and similar medicines have been slow to start, so many reports of the drugs’ effects on alcohol use have emerged that Leggio, Hendershot and other researchers warned in a commentary in the journal Nature Medicine that the drugs shouldn’t be prescribed for alcohol-use disorder until their safety and efficacy has been proven in clinical trials.
“Clinical decisions should follow from controlled studies, triangulated with other clinical and preclinical evidence,” the researchers wrote in the December commentary. “Well-controlled [trials] with scientific rigor are needed before any claim of efficacy for alcohol-use disorder and other substance use disorders can be made.”