The U.S. regulatory body has declared that a new iteration of the well-known diabetes medication Mounjaro can now be marketed as a weight-loss solution.

The drug Zepbound, also known as tirzepatide, has been approved by the U.S. Food and Drug Administration. In trials, it has shown to assist individuals in losing between 40 and 60 pounds.

Zepbound is the most recent medication for diabetes that has been authorized for long-term weight control. It is now available alongside Novo Nordisk’s Wegovy, which is a higher dose of their diabetes medication Ozempic. Both of these treatments require weekly injections.

The FDA has given the green light for Lilly’s medication to be used by individuals who have a body mass index of 30 or above and are classified as obese, or by those who are overweight and have a health condition such as high blood pressure, high cholesterol, or diabetes. The FDA stated that the medication should be combined with a reduced-calorie diet and consistent exercise.

In the United States, approximately 100 million adults and 15 million children are classified as obese.

The drugs tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that kick in after people eat to regulate appetite and the feeling of fullness. Both imitate a hormone called glucagon-like peptide-1, known as GLP-1. Tirzepatide targets a second hormone, called glucose-dependent insulinotropic polypeptide, or GIP.

The FDA approved Zepbound after reviewing two significant studies. One study involved over 2,500 participants who received varying doses of Zepbound, while the other had nearly 1,000 participants who received placebo shots. Over a period of 16 months, those without diabetes who received the highest dose of Zepbound lost approximately 18% of their body weight, equivalent to around 41 pounds (19 kilograms). Participants with diabetes, who typically struggle with weight loss, saw a decrease of about 12%, or approximately 27 pounds (12 kilograms), according to the FDA.

In a recent study, this medication was found to aid in weight loss of up to 25%, equivalent to 60 pounds (27 kilograms), when used in conjunction with strict diet and exercise.

In general, it seems that Zepbound leads to more significant weight loss compared to Wegovy. Wegovy was approved in 2021 for weight loss and according to research findings, it aided individuals in losing approximately 15% of their body weight or 34 pounds (15 kilograms).

Dr. Fatima Cody Stanford, an expert in obesity medicine at Massachusetts General Hospital in Boston, stated that this drug would be the most effective treatment for obesity ever approved.

Celebrity endorsements and social media buzz have led to high demand for semaglutide and tirzepatide drugs, causing their manufacturers to struggle with supply. The FDA has listed both drugs on their drug shortage site for several months. While all strengths of tirzepatide are currently reported as available, a spokesperson for the company stated that availability may vary depending on location and demand.

Possible rewording: Adverse reactions associated with the novel weight-loss medication include vomiting, queasiness, diarrhea, and constipation, as well as other gastrointestinal issues. In the latest clinical trial report, approximately 10% of participants on tirzepatide discontinued their participation due to these complications, while only 2% of those receiving placebo injections withdrew from the study.

Although Zepbound’s approval was praised by experts, they expressed concern that it may not result in increased availability of the drug. This is because it has been prescribed off-label to aid in weight loss.

Dr. Katherine Saunders, an expert in obesity from Weill Cornell Medicine in New York and co-founder of a company specializing in obesity treatment, stated that a large number of patients will not have the means to pay for Zepbound unless they have insurance coverage. Additionally, numerous health plans do not cover expenses related to obesity care.

According to Eli Lilly and Co., the monthly list price for Zepbound will be approximately $1,000, which is equivalent to the price of Mounjaro. The company also announced that the medication will be accessible in the United States before the year’s end. The dosing strengths for both Zepbound and Mounjaro are identical.

In 2021, Kelly Burns, a 50-year-old from St. Petersburg, Florida, participated in a study for tirzepatide to address obesity and successfully lost almost 100 pounds (45 kilograms). After the study concluded and she could no longer take the medication, she faced challenges but ultimately managed to lose an additional 50 pounds (23 kilograms).

“I have experienced a complete transformation in my life,” she stated. Her health metrics have shown improvement and her self-assurance has skyrocketed. With the approval for weight loss, Burns intends to inquire with her insurance provider about potential coverage.

She stated that it would be absurd not to and expressed her desire to maintain this state for as long as possible.

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The Health and Science Department of the Associated Press is aided by the Science and Educational Media Group of the Howard Hughes Medical Institute. The AP is fully accountable for all of its content.