A drug recently approved 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 and is involved in sending filling signals from the gut to the brain..
Researchers noticed that people who took the drug for diabetes also lost weight. The new study focused on people who are obese without diabetes and found even more weight loss.
Those who took the highest of three studied doses lost as much as 21% of their body weight ̵[ads1]1; as many as 50-60 pounds in some cases.
Nothing has provided that kind of weight loss other than surgery, said Dr. Robert Gabbay, chief scientist and medical officer of the American Diabetes Association. The entire study was presented Saturday at the ADA’s annual convention in New Orleans and simultaneously published in the New England Journal of Medicine.
Another obesity treatment approved last year called semaglutide, from Novo Nordisk, gives an average of up to approx. 15% weight loss. Previously Generations of diet medications cut only about 5% of the weight and many had insurmountable side effects.
“We have not had tools like this,” Gabbay said. – I think it is very exciting.
For most of the trial participants, the side effects of tirzepatide were not serious, said Jeff Emmick, vice president of product development for the diabetes department of drug giant Lilly, which produces the drug.
About 15% of participants who received the active substance dropped out of the 72-week study, about a third due to gastrointestinal side effects. Meanwhile, 26% of the volunteers who received placebo dropped out. Emmick said he thinks they may have been frustrated by the 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 have an updated timeline from the FDA later this year, Emmick said. Before approving the drug for weight loss, the regulatory body may first want Lilly to complete other ongoing studies examining 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.
An earlier study of tirzepatide in diabetes showed that half of the participants who were early in the course of diabetes went into remission while taking the drug.
“There is a potential game-changer in how we think about therapy for people with type 2 diabetes,” he said.
What is not yet known, Gabbay said, is whether remission achieved in this way will reduce the typical complications of diabetes, which can include cardiovascular disease, nerve and kidney damage and amputations of limbs.
It is also unclear whether tirzepatide will provide the cardiovascular benefits of semaglutide, said Dr. David Rind, a primary care physician and chief physician at the Boston-based Institute for Clinical and Economic Review.
It would be useful, Rind said, to run a head-to-head test between the two drugs to see if there are any differences in their health benefits.
“The question is, is tirzepatide one step better than all these (other weight loss) medications?” in Rind. “There is certainly reason to believe that it may be so, but I do not think it has been proven yet.”
Positive side effect
It has certainly made a difference for Mary Bruehl, 63, from Norman, Oklahoma.
She joined the diabetes study for tirzepatide in August 2019 because she had heard that weight loss can be a drug side effect. After years of “doing everything right”, Bruehl’s diabetes and weight control had fallen.
A hip prosthesis had almost immobilized her, which led to weight gain and lack of energy. “It seemed like there was nothing I could do to get it off,” said Bruehl, a lawyer. “My stomach did not know an end to all the food in the world.”
Diagnosed with fatty liver disease in June 2019, a worried Bruehl started skipping breakfast – apart from coffee – to cut down on calories and lose some weight.
She started with tirzepatide in September, and began to lose 5 to 10 kilos a month. By 1 July 2020, she had lost almost 60 kilos, which gave her one of the best results so far from the drug.
The more Bruehl lost, the better she felt and the more she was able to resume weekend trips and other physical activities, she said, which helped her feel even better.
The drug prevented her from overeating, Bruehl said. If she exaggerated, the food would come up again. “I learned to stop before I get that feeling,” she said.
Bruehl no longer needed metformin for her diabetes, and the fatty liver disappeared. The one negative side effect was nausea, which Bruehl felt the day after each of her weekly tirzepatide shots. A nausea pill that morning took care of it, she said.
The biggest challenge for Bruehl was to adapt to how differently people treated her after the weight loss. “I went to body image counseling and to work through some of the issues I had,” she said, adding that she needed time to accept what she saw in the mirror and stop reacting angrily to comments about her new figure. “It took a while to get comfortable in my own skin again.”
Bruehl started dating after being single for many years and now has a long-term partner.
“I feel more well rounded. I feel like I’m more myself now,” she said. “This trial gave me my life back.”
The new tirzepatide study, called SURMOUNT-1, included 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 average BMI for the participants was 38, 70% were white and almost as many women. Almost everyone on the drug saw an improvement in blood sugar, blood pressure and lipid levels. The trial started in December 2019 and was completed despite the ongoing COVID-19 pandemic.
Dr. Ania Jastreboff, a specialist in obesity medicine at Yale Medicine who helped lead the study, said that her patients responded in a number of ways to tirzepatide, just as they would in any other medicine, and some did not benefit from it. at all. But nine out of 10 lost weight, and at the highest dose, 15 mg, they lost an average of 52 kilos each.
Drugs such as semaglutide and now tirzepatide “enable us to actually care for our patients the way we need to care for them,” Jastreboff said. “They effectively re-regulate biology and help people regain body weight.”
Jastreboff said she has been able to help most of her patients through the side effects of the newer weight loss drugs, either by cutting back on certain foods or by eating less in general. “If you eat past the saturation point” on these medications, she said, “you’ll feel like you ate three Thanksgiving dinners.”
Jastreboff said she often has to help patients through the self-blame they feel for carrying extra pounds. She sees obesity not as an individual’s fault, but as a fight against biology’s urge to keep extra pounds. “These drugs target that physiology safely and effectively,” she said.
Patients must continue on weight loss medications, just as with medications to treat other chronic conditions, such as diabetes, high cholesterol and high blood pressure, she said. It is possible that when they maintain a lower weight for a certain period, they will be able to continue at a lower dose or even cut down completely, but that needs to be studied, she said.
An obstacle for many people will be the price of weight loss medications.
It’s too early to know what price Lilly will set for tirzepatid. Mounjaro, the same drug used to treat diabetes in the same doses, is sold for just under $ 1,000 a month.
Semaglutide came on the market last year for weight loss and has been in short supply since then, Rind said. It costs around $ 1600 a month for the 2.4 mg weight loss dose, which is higher than the 1 or 2 mg doses used to treat diabetes. Like other weight loss drugs, semaglutide is not covered by many insurance plans.
“Access and costs – this is something we as suppliers work with every day,” said Jastreboff.
Bruehl recently started on a low dose of semaglutide to treat her diabetes and the weight that has started to creep back. The insurance covers everything except around $ 30 a month.
She’s okay with the fact that she probably has to take it forever to keep the weight off, just as her hereditary risk of diabetes means she’s probably have to treat it forever as well. Exercise and careful eating must also be part of her ongoing diet, she said.
“This is going to take a lifelong dedication.”
Contact Karen Weintraub at firstname.lastname@example.org.
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