With a growing number of overweight Americans clamoring for Ozempic and Wegovy — drugs touted by celebrities and on TikTok for shedding pounds — an even more potent obesity drug is set to shake up the treatment.
Tirzepatide, an Eli Lilly and Co. drug approved to treat type 2 diabetes under the brand name Mounjaro, has helped overweight or obese people with the disease lose up to 16% of their body weight, or more of 34 pounds, over nearly 17 months, the company announced Thursday.
The late-stage study of the weight-loss drug adds to previous evidence that similar participants without diabetes lost up to 22% of their body weight over this period with weekly injections of the drug. For a typical patient on the highest dose, this meant losing over 50 pounds.
Diabetes makes it notoriously difficult to lose weight, said Dr Nadia Ahmad, medical director of obesity clinical development at Lilly, meaning the recent findings are particularly significant. “We haven’t seen that degree of weight reduction,” she said.
Based on the new results, which have yet to be released in full, company officials said they will finalize an application with the U.S. Food and Drug Administration for expedited sale approval. of tirzepatide for chronic weight management. A decision could come later this year. A company spokeswoman did not confirm whether the drug would be marketed for weight loss in the United States under a different brand name.
If approved for weight loss, tirzepatide could become the most effective drug yet in an arsenal of drugs that are transforming the treatment of obesity, which affects more than 4 in 10 American adults and is linked to dozens of diseases that can lead to disability or death.
“If everyone who was obese in this country lost 20% of their body weight, we would be taking all those drugs for reflux, diabetes, hypertension out of patients,” said Dr. Caroline Apovian, director of the Center for Weight. Management and Welfare at Brigham and Women’s Hospital. “We would not send patients for stent replacement.”
Industry analysts predict tirzepatide could become one of the best-selling drugs of all time, with annual sales exceeding $50 billion. It is expected to overtake Novo Nordisk’s Ozempic – a diabetes drug used so commonly for weight loss that comedian Jimmy Kimmel joked about it at the Oscars – and Wegovy, a version of the drug also known as semaglutide approved for weight loss. weight in 2021. Together, these drugs brought in nearly $10 billion in 2022 as prescriptions continue to soar, according to company reports.
In separate trials, tirzepatide caused greater weight loss than semaglutide, whose users lost around 15% of their body weight over 16 months. A comparative trial comparing the two drugs is planned.
Mounjaro was first approved to treat diabetes last year. Since then, thousands of patients have obtained the drug from doctors and telehealth providers who have prescribed it “off label” to help them lose weight.
In California, Matthew Barlow, a 48-year-old health-tech executive, said he’s lost more than 100 pounds since November by using Mounjaro and changing his diet.
“Psychologically, you don’t want to eat,” Barlow said. “Now I can eat two bites of dessert and be satisfied.”
Rather than relying solely on diet, exercise and willpower to lose weight, tirzepatide and other new drugs target the digestive and chemical pathways that underlie obesity, suppressing appetite and alleviating food cravings.
“They completely changed the landscape,” said Dr. Amy Rothberg, a University of Michigan endocrinologist who leads a virtual weight loss and diabetes program.
Research has shown that with diet and exercise alone, about one-third of people will lose 5% or more of their body weight, said Dr. Louis Aronne, director of Weill Cornell Medicine’s Comprehensive Weight Control Center. In the latest tirzepatide trial, more than 86% of patients using the highest dose of the drug lost at least 5% of their body weight. More than half of that dose lost at least 15%, the company said.
Obesity drugs help overcome a biological mechanism that kicks in when people diet, triggering a coordinated effort by the body to prevent weight loss.
“It’s a real physical phenomenon,” Aronne said. “There are a number of hormones that respond to reduced calorie intake.”
Ozempic and Wegovy are two versions of semaglutide. This drug mimics a key gut hormone, known as GLP-1, which is activated after people eat, stimulating the release of insulin and slowing the release of sugar from the liver. It delays digestion and reduces appetite, which makes people feel full longer.
Tirzepatide is the first drug to use the action of two hormones, GLP-1 and GIP, for greater effects. It also targets chemical signals sent from the gut to the brain, curbing food cravings and thoughts.
Although the drugs seem safe, they can cause side effects, some of them serious. The most common reactions are diarrhea, nausea, vomiting, constipation and stomach pain. Some users have developed pancreatitis or inflammation of the pancreas, others have had gall bladder problems. Mounjaro’s product description warns that it could cause thyroid tumors, including cancer.
There are other downsides: versions of semaglutide have been on the market for several years, but the long-term effects of taking drugs that override human metabolism are still unclear. Early evidence suggests that when people stop taking the drugs, they gain weight.
In addition, the drugs are expensive – and in recent months hard to come by due to intermittent shortages. Wegovy costs around $1,300 per month. Mounjaro used for diabetes starts at around $1,000 per month.
Apovian said only 20 to 30 percent of patients with private insurance in his practice find the drugs covered. Some insurers that previously paid for the drugs are enacting new rules, requiring six months of documented lifestyle changes or some weight loss for continued coverage. Medicare is largely barred from paying for weight-loss drugs, though drugmakers and congressional advocates have been pushing to change that.
Still, experts say the striking effects of tirzepatide — along with Ozempic, Wegovy and other drugs — underscore that losing weight isn’t just about willpower. Like high blood pressure, which affects about half of American adults and is managed with medication, obesity should be viewed as a chronic condition and not a character flaw, Aronne stressed.
It remains to be seen what effect new drug treatments will have on widespread prejudice against obese people, said Rebecca Puhl, a professor at the Rudd Center for Food Policy and Health who studies weight stigma. American culture has “deeply ingrained beliefs about body weight and physical appearance” that are hard to change, she said.
“Weight stigma could persist or worsen if taking medication is equated with ‘taking the easy way out’ or ‘not trying hard enough,'” she said.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.