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Ozempic maker Novo Nordisk says it will study the drug’s effects on alcohol use, but is not focusing on addiction



CNN

When Cheri Ferguson started taking Ozempic last year, she said, she hoped to lose about 50 pounds she had gained during the Covid-19 pandemic.

For about three months, she told CNN in June, the drug — which is approved for type 2 diabetes and used off-label for weight loss — helped reduce the constant chatter in her brain. enticing her to eat, exactly what she was hoping for. would do.

But it had another unexpected effect: Ferguson said his desire to drink alcohol and use his vape pen also went away.

“It’s like someone just came in and turned on the light, and you can see the room for what it is,” she said. “And all those vapes and cigarettes you’ve been doing over the years don’t look appealing anymore. It’s very, very strange. Very strange.”

It’s a feeling described by thousands of people taking the drugs, which belong to a class known as GLP-1 receptor agonists and are used by about 15 million Americans, according to a recent survey. And now Ozempic’s maker, Novo Nordisk, has announced plans to study the phenomenon.

The company plans to begin evaluating the effects of semaglutide, the active ingredient in Ozempic, and other medications on alcohol consumption this month in a recently announced clinical trial for liver disease linked to alcohol – although reducing alcohol consumption was not the main aim of the study.

The Danish pharmaceutical giant has said since at least last year that it does not plan to study semaglutide – which is also approved for weight loss under the name Wegovy – in areas like alcohol dependence , despite numerous anecdotal reports like Ferguson’s and academic studies that are already underway.

Novo Nordisk reiterated that position Wednesday, noting that the main goal of its new trial is to evaluate whether the drugs can improve liver health. Its main measure is the effect of the drugs on improving liver fibrosis, or scarring, over 28 weeks.

“Secondary endpoints include safety, tolerability and changes in alcohol consumption,” a Novo Nordisk spokesperson said in an email. “There is a significant unmet medical need for alcohol-related liver disease, and the first line of treatment for this disease is lifestyle intervention aimed at abstaining from alcohol. »

The trial, first reported by Bloomberg News, aims to recruit about 240 participants and is expected to begin May 20, according to a government database.

“Even though not all patients in the trial will suffer from alcohol use disorders, it is natural to include alcohol consumption as a secondary endpoint,” the Novo spokesperson said. Nordisk, emphasizing that the trial is part of the company’s plans to combat liver disease more broadly.

Nonetheless, addiction science researchers applauded the news.

“Those of us who work in this area see this as a step in the right direction,” Christian Hendershot, assistant professor in the Department of Psychiatry and the Bowles Center for Alcohol Studies at the University of North Carolina in Chapel Hill, which is leading one of the few studies in this area, said Wednesday by email. “Additional treatment options for this group are greatly needed.” »

Novo Nordisk’s CEO told CNN in August that the company had heard many similar anecdotal reports.

“We know that one of the benefits of obesity is that it satisfies this craving, this desire to snack and eat,” said Lars Fruergaard Jorgensen. “This function in the brain, in this craving center, is perhaps also what benefits some of the other addictions.”

Animal studies suggest the same thing, Dr. Lorenzo Leggio, a researcher at the National Institutes of Health, told CNN last year. He published a study in May 2023 showing that semaglutide reduces alcohol consumption in rodents, noting that “at least one of the mechanisms by which these drugs reduce alcohol consumption is by reducing the rewarding effects of alcohol”, such as those linked to the neurotransmitter dopamine.

Jorgensen said Novo Nordisk had not studied this effect and did not intend to do so at the time.

“It’s not the easiest to study,” he noted. “It should not be expected that we are going to study these dependencies on a large scale.”

Jorgensen said there could be “an opportunity to collect data when we do large-scale studies,” as well as use artificial intelligence to mine large databases of experiences with drugs in the real world looking for signals of effects on things like alcohol consumption.

A spokesperson for Eli Lilly, which makes tirzepatide-based competitors from Ozempic and Wegovy called Mounjaro and Zepbound, said Wednesday that it had also seen “anecdotal comments in publications about the potential use of GLPs -1 for additional indications such as dependence.

But while the Indianapolis-based drugmaker continues to “evaluate future development options for tirzepatide,” the spokesperson said the company has not announced any plans to develop its drugs for those uses.

Medications for addiction, and particularly for alcohol use, have not been financially successful for the pharmaceutical industry, leading pharmaceutical companies to show less interest in drug development in this area.

A study by financial firm TD Cowen found that fewer than 5 percent of the 29 million Americans suffering from alcohol use disorder are receiving medication-assisted treatment. The company highlighted issues such as doctors’ lack of knowledge with medications to treat alcohol use and medication adherence.

Novo Nordisk is studying several drugs in its recently announced alcohol-related liver disease trial; In addition to semaglutide, the company said it would study the experimental drugs cagrilintide and another called zalfermin — listed on the trial as NNC0194-0499 — alone or in combination.

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Cagrilintide is a drug that mimics a hormone called amylin that Novo Nordisk is testing in combination with semaglutide – which mimics another hormone, called GLP-1 – in large-scale trials in diabetes and weight loss , under the name of CagriSema. Zalfermin, according to the company, acts like another metabolic hormone, FGF21, which is produced primarily in the liver.

Although trials of the use of semaglutide and similar drugs have been slow to get underway, so many reports on the effects of these drugs on alcohol consumption have been published that Leggio, Hendershot and other researchers have warned in a commentary in the journal Nature Medicine that medications should not be prescribed for alcohol use disorders until their safety and effectiveness have been proven in clinical trials.

“Clinical decisions should arise from controlled studies, triangulated with other clinical and preclinical evidence,” the researchers wrote in the December commentary. “Well-controlled and rigorous (trials) are needed before any claims of effectiveness for alcohol use disorder and other substance use disorders can be made.” »

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