FDA approves new drug resulting in 50+ pound weight loss

[Apr. 7, 2023: JD Shavit, The Brighter Side of News]

According to a recent study published in the New England Journal of Medicine, people with obesity who were treated with the novel drug tirzepatide lost an average of 52 pounds. The study, called “Tirzepatide Once Weekly for the Treatment of Obesity,” reports that significant weight reduction can be attained with tirzepatide. This marks a significant development in the field of obesity treatment, as tirzepatide offers an alternative to traditional weight loss methods.

The study involved a Phase 3 trial, called SURMOUNT-1, which investigated the efficacy and safety of tirzepatide. The study included 2,539 participants with obesity who were randomized to receive a placebo, tirzepatide 5 mg, tirzepatide 10 mg, or tirzepatide 15 mg for 72 weeks. The average body mass index (BMI) of study participants was 38 kg/m2, and they weighed an average of 231 lbs.

At the end of the study, those taking the 15 mg dose of tirzepatide had an average body weight reduction of 22.5%. 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.

“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. Jastreboff, the site-PI for SURMOUNT-1 at Yale, presented findings from the study at the American Diabetes Association Scientific Sessions in New Orleans on June 4.

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“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.”

The drug trial’s sponsor, Eli Lilly, is currently working with the FDA on a timeline for approval of tirzepatide as a treatment for obesity. Tirzepatide was FDA-approved for the treatment of type 2 diabetes and is now commercially available for that use. However, it is not yet FDA-approved as an anti-obesity medication for the treatment of obesity.

Obesity is a serious public health issue in the United States. According to the Centers for Disease Control and Prevention (CDC), over 42% of American adults are obese. This puts them at an increased risk for heart disease, stroke, type 2 diabetes, and certain types of cancer. Obesity also increases the risk of severe illness from COVID-19.

In recent years, there has been a growing interest in finding new ways to treat obesity. Traditional weight loss methods, such as diet and exercise, have limited success for many people. Bariatric surgery is a more effective treatment option, but it is not appropriate for everyone. This has led to a need for new medications that can help people lose weight safely and effectively.

Tirzepatide is a novel medication that works as a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. GIP and GLP-1 are hormones that are secreted by the gut in response to food intake and play important roles in regulating insulin secretion, glucose metabolism, and appetite.

By activating both GIP and GLP-1 receptors, tirzepatide can improve glycemic control and promote weight loss by reducing hunger, increasing feelings of fullness, and slowing down the absorption of nutrients from the gut.

During preclinical, phase I, and phase II clinical trials, tirzepatide exhibited adverse effects that were similar to those of other established GLP-1 receptor agonists, such as dulaglutide. These effects were primarily gastrointestinal in nature, with the most frequently reported adverse events being nausea, diarrhea, and vomiting. The incidence of these side effects increased with higher dosage amounts of tirzepatide. Additionally, as the dosage increased, a higher number of patients discontinued taking tirzepatide, with patients taking the highest dose (15 mg) having a 25% discontinuation rate compared to 5.1% for those taking 5 mg and 11.1% for those taking dulaglutide.

It is worth noting that despite the gastrointestinal side effects, most patients in the clinical trials were able to tolerate tirzepatide well and experienced significant weight loss. To a slightly lesser extent, patients also reported reduced appetite. Other side effects reported were dyspepsia, constipation, abdominal pain, dizziness and hypoglycaemia.

Nonetheless, further studies are needed to fully understand the safety profile of tirzepatide, especially with long-term use and in populations with coexisting medical conditions.

Healthcare providers should closely monitor patients who are taking tirzepatide and adjust the dosage as needed to minimize the risk of adverse effects.

Note: Materials provided above by The Brighter Side of News. Content may be edited for style and length.

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