People lost over 50 pounds using new FDA-approved pill

[Dec. 7, 2022: Jane E. Dee, Yale School of Medicine]

Because it can be taken orally, it’s much simpler for the patient to stay compliant with his or her treatment. (CREDIT: Creative Commons)

People with obesity treated with a weekly dose of Tirzepatide, a novel GIP/GLP-1 receptor agonist which is sold under the brand name Mounjaro, lost about 52 pounds on average, according to results of a new study that were published in New England Journal of Medicine.

Recently approved by the US Food and Drug Administration to treat type 2 diabetes, Tirzepatide, may help adults without diabetes lose weight as well, the study found.

“In this study, about nine out of 10 individuals with obesity lost weight,” said Ania Jastreboff, MD, PhD, associate professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) at Yale School of Medicine and the lead author of the study.

The study included 2,539 participants with obesity who were randomized to receive placebo, tirzepatide 5 mg, tirzepatide 10mg, or tirzepatide 15 mg for 72 weeks. Study participants on average had a body mass index (BMI) 38 kg/m2 and on average weighed 231 lbs.

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At the end of the study, those taking the 15 mg dose of tirzepatide had an average body weight reduction of 22.5%. People without diabetes lost an average of 15% to 20.9% of their starting body weight over the course of the clinical trial.

Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. Treatment with all three doses of tirzepatide resulted in substantial and sustained body weight reduction, the study’s authors said. Side effects were primarily gastrointestinal, and included nausea, vomiting and diarrhea, and mainly occurred in the dose-escalation phase.

Nothing has provided that kind of weight loss except surgery, said Dr. Robert Gabbay, chief scientific and medical officer for the American Diabetes Association.

Jastreboff, the site-PI for SURMOUNT-1 at Yale, presented findings from the study at the American Diabetes Association Scientific Sessions in New Orleans.

“These results are an important step forward in potentially expanding effective therapeutic options for individuals with obesity,” said Jastreboff, who is the director of Weight Management and Obesity Prevention at the Yale Stress Center and co-director of the Yale Center for Weight Management. “Obesity should be treated like any other chronic disease – with effective and safe approaches that target underlying disease mechanisms; these results underscore that tirzepatide may be doing just that.”

Ania Jastreboff, MD, PhD, associate professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) at Yale School of Medicine (CREDIT: Yale School of Medicine)

Currently, tirzepatide is not FDA-approved as an anti-obesity medication for the treatment of obesity. Tirzepatide was FDA-approved for the treatment of type 2 diabetes and is now commercially available for that use.

The drug trial’s sponsor, Eli Lilly, is working with the FDA on a timeline for approval of tirzepatide as a treatment for obesity.

Adverse effects

Preclinical, phase I, and phase II clinical trials indicated that tirzepatide exhibits adverse effects similar to those of other established GLP-1 receptor agonists, such as dulaglutide. These effects occur largely within the gastrointestinal tract.

In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight. (CREDIT: New England Journal of Medicine)

The most frequently observed are nausea, diarrhea and vomiting, which increased in incidence with the dosage amount (i.e. higher likelihood the higher the dose). The number of patients who discontinued taking tirzepatide also increased as dosage increased, with patients taking 15 mg having a 25% discontinuation rate vs 5.1% for 5 mg patients and 11.1% for dulaglutide.

To a slightly lesser extent, patients also reported reduced appetite. Other side effects reported were dyspepsia, constipation, abdominal pain, dizziness and hypoglycaemia.

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Note: Materials provided above by Yale School of Medicine. Content may be edited for style and length.

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