A recently approved drug to treat type 2 diabetes is also extremely effective in reducing obesity, according to a new study.
The drug, called tirzepatide, acts on two naturally occurring hormones that help control blood sugar levels and are involved in sending fullness signals from the gut to the brain†
Researchers noted that people who took the drug for their diabetes also lost weight. The new trial focused on obese people without diabetes and found even more weight loss.
Those who took the highest of the three doses studied lost as much as 21% of their body weight — as much as 50-60 pounds in some cases.
Nothing has caused that kind of weight loss except surgery, said Dr. Robert Gabbay, chief scientific and medical officer of the American Diabetes Association. The full study was presented Saturday at the ADA’s annual convention in New Orleans and was published simultaneously in the New England Journal of Medicine.
Another obesity treatment approved last year, called semaglutide, from Novo Nordisk, averages up to about 15% weight loss. Last Generations of diet drugs only reduced weight by about 5%, and many had prohibitive side effects.
“We haven’t had such tools yet,” Gabbay said. “I find it very exciting.”
For most trial participants, tirzepatide’s side effects were not serious, said Jeff Emmick, vice president of product development for the diabetes division of drug giant Lilly, which makes the drug.
About 15% of participants who received the active drug discontinued the 72-week trial, about a third due to gastrointestinal side effects. Meanwhile, 26% of the trial volunteers who were given a placebo quit. Emmick said he thinks they may have been frustrated with their lack of weight loss.
On May 13, the Food and Drug Administration approved tirzepatide, under the trade name Mounjaro, for the treatment of type 2 diabetes.
Tirzepatide is not yet available for weight loss, but Lilly hopes to file data with the FDA later this year, Emmick said. Before approving the weight-loss drug, the regulatory agency may want Lilly to complete other studies that examine tirzepatide in people with obesity and diabetes and the addition of lifestyle changes to the drug regimen.
Weight loss of 15% to more than 20% also has the potential to change the way doctors treat diabetes, Gabbay said, from focusing on lowering blood sugar to aiming for total remission.
A previous study of tirzepatide in diabetes showed that half of the participants who went into remission early in the course of their diabetes while taking the drug.
“That’s a potential game-changer in how we think about therapy for people with type 2 diabetes,” he said.
What’s not yet known, Gabbay said, is whether remission achieved in this way will reduce the typical complications of diabetes, including cardiovascular disease, nerve and kidney damage and limb amputations.
It’s also still unclear whether tirzepatide will provide the cardiovascular benefits that semaglutide provides, said Dr. David Rind, a primary care physician and chief medical officer of the Boston-based Institute for Clinical and Economic Review.
It would be helpful, Rind said, to conduct a direct trial between the two drugs to see if there are any differences in their health benefits.
“The question is, is tirzepatide a step better than all those (other) weight loss drugs?” said Rind. “There is certainly reason to believe it is, but I don’t think it has been proven yet.”
Positive side effect
It certainly made a difference to Mary Bruehl, 63, of Norman, Oklahoma.
She took part in the diabetes trial for tirzepatide in August 2019 because she had heard that weight loss could be a side effect of the drug. After years of “doing everything right,” Bruehl’s diabetes and weight management were gone.
A hip replacement nearly immobilized her, leading to weight gain and a lack of energy. “It seemed like I couldn’t do anything to get it off,” said Bruehl, a lawyer. “My stomach knew no end to all the food in the world.”
Diagnosed with fatty liver in June 2019, a concerned Bruehl began skipping breakfast — except coffee — to cut calories and lose some weight.
She started tirzepatide in September and started losing 5 to 10 pounds per month. By July 1, 2020, she had lost nearly 60 pounds, which gave her one of the best results she’d seen with the drug to date.
The more Bruehl lost, the better she felt and the more she was able to resume weekend walks and other physical activities, she said, which made her feel even better.
The drug kept her from eating too much, Bruehl said. If she overeat, the food would come back up. “I’ve learned to stop before I get that feeling,” she said.
Bruehl no longer needed metformin for her diabetes and her fatty liver disappeared. The only negative side effect was nausea, which Bruehl felt the day after each of her weekly injections of tirzepatide. An anti-nausea pill that morning took care of it, she said.
The biggest challenge for Bruehl was adjusting to how differently people treated her after the weight loss. “I went to some body image counseling and to resolve some of the issues I was having,” she said, adding that she needed time to accept what she saw in the mirror and stop being angry. to respond to comments about her new figure. “It took a while before I was comfortable in my own skin again.”
Bruehl started dating after years of being single and now has a long-term partner.
“I feel more round. I feel like I’m more myself now,” she said. “This lawsuit has given me my life back.”
The new tirzepatide study, called SURMOUNT-1, involved more than 2,500 volunteers who either met the medical definition of obesity, had a body mass index of 30 or higher, or had a slightly lower BMI but at least one weight-related health problem.
The mean BMI for participants was 38, 70% were white and almost as many women. Nearly everyone who took the drug saw an improvement in blood sugar, blood pressure, and lipid levels. The trial began in December 2019 and was completed despite the ongoing COVID-19 pandemic.
dr. Ania Jastreboff, an obesity medicine specialist at Yale Medicine who helped lead the trial, said her patients responded to tirzepatide in different ways, just like they would to any other drug, with some showing no benefit at all. But nine out of ten lost weight, and at the highest dose, 15 mg, they lost an average of 52 pounds each.
Drugs like semaglutide and now tirzepatide “allow us to care for our patients the way we should care for them,” Jastreboff said. “They effectively re-regulate biology and help people recover their body weight.”
Jastreboff said she has been able to help most of her patients through the side effects of the newer weight loss medications, either by cutting back on certain foods or by eating less in general. “If you eat past the point of fullness” with these drugs, she said, “you will feel like you’ve eaten three Thanksgiving dinners.”
Jastreboff said she often has to help patients through the guilt they feel for carrying on extra pounds. She sees obesity not as an individual’s fault, but as a battle against biology’s urge to hold on to extra pounds. “These drugs safely and effectively target that physiology,” she said.
Patients will need to continue taking weight-loss drugs, as they would with drugs to treat other chronic conditions, such as diabetes, high cholesterol and high blood pressure, she said. It’s possible that once they lose weight over a period of time, they’ll be able to continue on a lower dose or even cut it completely, but that needs to be studied, she said.
One barrier for many people is the price of weight loss drugs.
It’s too early to know what price Lilly will set for tirzepatide. Mounjaro, the same drug used to treat diabetes in the same doses, retails for just under $1,000 a month.
Semaglutide hit the weight-loss market last year and has been in short supply since then, Rind said. It costs about $1,600 per month for the 2.4 mg dose for weight loss, which is higher than the 1 or 2 mg doses used to treat diabetes. Like other weight loss medications, semaglutide is not covered by many insurance plans.
“Access and cost — that’s something we as providers work on every day,” says Jastreboff.
Bruehl recently started on a low dose of semaglutide to treat her diabetes and the weight that started to creep back. Insurance covers all but about $30 a month.
She’s fine with the fact that she’ll probably have to take it forever to maintain her weight, just as her hereditary diabetes risk means she’ll probably have to treat that forever too. Exercise and careful eating will also need to be part of her ongoing regimen, she said.
“This is going to take a lifetime of dedication.”
Contact Karen Weintraub at kweintr[email protected]
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