A new study shows that a drug recently approved to treat type 2 diabetes is highly effective in reducing obesity.
The drug, called tirzepatide, works on two naturally occurring hormones that help control blood sugar and are involved in sending signals of fullness from the gut to the brain.
The researchers noted that people who took the drug to treat their diabetes also lost weight. The new trial focused on obese people without diabetes and found more weight loss.
Those who took the three highest studied doses lost up to 21% of their body weight — up to 50-60 pounds in some cases.
Nothing has offered this type of weight loss except for surgery, said Dr. Robert Gabbai, chief scientific and medical officer of the American Diabetes Association. The full study was presented Saturday at the ADA’s annual conference in New Orleans and simultaneously published in New England Journal of Medicine.
Another obesity treatment approved last year called semaglutide, from Novo Nordisk, provides on average up to about 15% weight loss. Previous generations of diet drugs only reduced about 5% of the weight and many had exorbitant side effects.
“We didn’t have tools like these,” Gabbay said. “I think it’s really exciting.”
For most of the trial participants, Jeff Emick, vice president of product development for diabetes at drug giant Lilly, said the side effects of terzipatide were not serious.
About 15% of the participants who received the active drug withdrew from the 72-week trial, and about a third because of gastrointestinal side effects. Meanwhile, 26% of the experimental volunteers who received a placebo quit. Emek said he thinks they may have been frustrated by their lack of weight loss.
On May 13, the Food and Drug Administration approved tirzepatide, under the brand name Mounjaro, to treat type 2 diabetes.
Emek said terzepeptide is not yet available for weight loss, but Lilly hopes to receive an updated schedule from the Food and Drug Administration later this year. Before approving a weight-loss drug, the regulatory agency may first want Lilly to complete other ongoing studies examining tirzepatide in people with obesity and diabetes and to add lifestyle changes to the medication regimen.
Gabay said a weight loss of 15% to more than 20% also has the potential to change the way doctors treat diabetes, from focusing on lowering blood sugar to seeking complete remission.
A previous study of tirzepatide in diabetes showed that half of the participants who had early-onset diabetes went into remission while taking the drug.
“This is a potential factor in the way we think about treating people with type 2 diabetes,” he said.
What’s unknown so far, Gabay said, is whether achieving remission in this way will reduce the typical complications of diabetes, which can include cardiovascular disease, nerve damage, kidney and limb amputations.
It’s also unclear whether tirzepatide will provide the cardiovascular benefits that semaglutide does, said Dr. David Rend, MD, a primary care physician and medical officer at the Boston-based Institute of Clinical and Economic Review.
Rind said it would be useful to do a direct trial between the two drugs to see if there were any differences in their health benefits.
“The question is, is tirzepatide a better step than all of those[other weight loss]drugs?” Rand said. “There is certainly reason to believe it might be, but I don’t think it has been proven yet.”
Positive side effects
This definitely made a difference for Marie Broel, 63, of Norman, Oklahoma.
She joined the diabetes trial for tirzepatide in August 2019 because she had heard that weight loss might be a side effect of the drug. After years of “doing it all right,” Bruehl’s diabetes and weight control waned.
Her hip replacement nearly immobilized her, resulting in weight gain and a lack of energy. “It looked like I didn’t find anything I could do to get rid of him,” Barwell said. “My stomach didn’t know the end of all the food in the world.”
Diagnosed with fatty liver disease in June 2019, anxious Bruehl began skipping breakfast — except for coffee — to cut back on calories and lose a little weight.
Starting tirzepatide in September, I started shedding 5-10 pounds per month. By July 1, 2020, she had lost nearly 60 pounds, which gave her one of the best results seen so far from the drug.
She said the more Bruehl lost, the better she felt and the more she was able to resume weekend walks and other physical activities, which helped her feel better.
Bruell said the drug prevented her from overeating. If you overeat, the food will come back. “I’ve learned to stop before I get this feeling,” she said.
Proel no longer needed metformin to treat her diabetes and the fatty liver was cured. The only negative side effect was nausea, which I felt as broil the day after each weekly dose of terzipatide. She said she took an anti-nausea pill that morning.
Bruehl’s biggest challenge has been adapting to how people treat her differently after losing weight. “I went to some body image advice and worked out some of the issues I was having,” she said, adding that she needed time to accept what she was seeing in the mirror and to stop reacting furiously to comments about her new one. the shape. “It took a while for me to feel comfortable in my own skin again.”
Bruehl started dating after being single for many years and now has a long term partner.
“I feel much closer. I feel more myself now,” she said. “This trial gave me my life back.”
The new tirzepatide trial, called SURMOUNT-1, involved more than 2,500 volunteers who either met the medical definition of obesity, had a BMI of 30 or more, or had a slightly lower BMI but at least a weight-related health problem.
The average BMI of the participants was 38, and 70% were white and about as many as many females. Almost everyone who took the drug noticed an improvement in their blood sugar, blood pressure, and lipid levels. The trial began in December 2019 and was completed despite the ongoing COVID-19 pandemic.
Dr. Anya Gastropov, an obesity specialist at Yale Medical University, who helped lead the trial, said her patients responded in a variety of ways to terzipatide, just as they would any other drug, with some getting no benefit at all. But nine out of 10 lost weight, and on the highest dose, 15 mg, they lost an average of 52 pounds each.
Medicines like semaglutide and now tirzepatide “enable us to care for our patients the way we need to take care of them,” Gastropov said. “They effectively reorganize their biology and help people regain their body weight.”
Gastropov said she has been able to help most of her patients with the side effects of the latest weight-loss drugs, either by cutting back on certain foods or by eating less in general. “If you eat more than the point of fullness” on these medications, she said, you’ll feel like you ate three Thanksgiving dinners.
Jastreboff said she often has to help patients with the self-blame they feel for carrying extra pounds. She doesn’t see obesity as one’s fault, but as a battle against biology’s drive to keep extra weight. “These drugs target physiology safely and effectively,” she said.
She said patients will need to continue to take weight-loss medications, just as they would with medications to treat other chronic conditions, such as diabetes, high cholesterol and high blood pressure. It’s possible that once they maintain a lower weight for a certain period of time, she said, they will be able to continue on a lower dose or even reduce the weight completely, but this needs to be studied.
One barrier many people face is the price of weight loss drugs.
It’s too soon to know what price Lilly will set for tirzepatide. Moonjaro, the same drug used to treat diabetes in the same doses, sells for just under $1,000 a month.
Rend said Semaglutide was introduced to the market last year for weight loss and has been in short supply since then. It costs about $1,600 per month for a 2.4mg weight loss dose, which is higher than the 1 or 2mg dose used to treat diabetes. Like other weight-loss drugs, semaglutide is not covered by many insurance plans.
“Access and cost — that’s something we work with every day as service providers,” said Gastropov.
Bruehl recently started on a low dose of semaglutide to treat my diabetes and the weight was starting to creep in again. Insurance covers everything but about $30 a month.
She’s okay with the fact that she may need to take it forever to maintain the weight, just as her genetic risk of developing diabetes means she may need to take that forever too. She said exercising and eating carefully should be part of her ongoing regimen as well.
“This will take a lifetime of dedication.”
Tirzepatide noninferior, superior to semaglutide for T2DM
Ania M. Jastreboff et al, Tirzepatide once weekly for the treatment of obesity, New England Journal of Medicine (2022). doi: 10.1056/NEJMoa2206038
Clifford J. Rosen et al., Tides offer new hope for obesity, New England Journal of Medicine (2022). doi: 10.1056/NEJMe2206939
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