The experimental drug broke the record in weight loss in the latest results of clinical trials

The experimental drug, which is being clinically investigated for its effects on body weight in obese and obese people, has led to record weight loss for study participants – compared to surgical options, the company behind the drug suggests.

Tirzepatide, developed by the American pharmaceutical company Eli Lilly and Company (Lilly), is an injection once a week that promotes weight loss by mimicking the effects of natural hormones called incretins. These hormones lower blood sugar after we eat, in addition to regulating metabolic processes related to digestion.

In the case of tirzepatide, which is not yet available on the market until further clinical study, the drug is a synthetic combination of two specific incretins, called GLP-1 (glucagon-like peptide) and GIP (glucose-dependent insulinotropic polypeptide).

The former hormone, GLP-1, is the foundation of the anti-diabetes drug semagglutide, which was approved in the U.S. as a weight loss drug in 2021, marking the first time the FDA has approved a new weight loss treatment in a few years.

That approval was given on the back of the results described as a ‘game change’ for weight loss, but it looks like the tirzepatide formulation – thanks to the addition of GIP alongside GLP-1 – could change the game again.

In Phase 3 results of the ongoing SURMOUNT-1 clinical trial investigating the effects of tirzepatide, the researchers included 2,539 participants who were either overweight or obese (with one weight-related comorbidity but no type 2 diabetes).

Participants received tirzepatide or placebo for 72 weeks, along with support to follow a reduced-calorie diet and increase physical activity levels.

Tirzepatide was administered in one of three different doses (either 5, 10, or 15 milligrams per week injection), but all three groups reported significant levels of weight loss during the study.

At the highest dose (15 mg), participants saw an average weight loss of 22.5 percent of their body weight (24 kg or 52 lb), while a 10 mg dose achieved a weight loss of 21.4 percent (22 kg or 49 lb) and 5 mg saw a 16 percent reduction in body weight (16 kg or 35 lb).

By comparison, the placebo group lost only 2.4 percent of their body weight (2 kg or 5 lb). Previously, semagglutide weight loss trials averaged approximately 17 percent.

“Tirzepatide is the first drug to deliver more than 20 percent of weight loss in phase 3 on average,” says clinical research physician Jeff Emmick, vice president of product development at Lilly.

Although the results have not yet been reviewed, Lilly says they will be submitted for such consideration in the future. Meanwhile, a study in the SURMOUNT-1 trial is underway, with related SURMOUNT trials, the results of which are expected to be published in 2023.

However, we already know that tirzepatide does not agree with everyone who takes it. Although the average weight loss results appear to be slightly higher than semaglutide treatment and are approximately equal to those that patients who lose weight can expect from bariatric surgery, some participants in the tirzepatide-treated group experienced adverse effects.

Depending on the dose, up to one-third of the group on tirzepatide experienced nausea, while diarrhea was also relatively common (for 18.7–23 percent of participants). Some people also experienced vomiting and constipation, although it is worth noting that only a small percentage of participants dropped out of the study because of these effects.

Another potential hurdle to stomaching tirzepatide is the question of price – assuming that subsequent research results will persuade the FDA to approve the drug for patients who are losing weight, i.e. (the drug has already been submitted for regulatory review for diabetes treatment.)

As others have noted, semaglutide – sold as a weight loss drug under the Wegovy brand by Danish pharmaceutical company Novo Nordisk – sells for more than $ 1,300 a month, and very few patients can afford such an expensive drug, especially when Medications like this rarely cover health insurance.

If tirzepatide follows a similar pricing strategy – after an expected but not yet secured future release – this could be another case of a potentially brilliant, life-changing drug that many people will unfortunately not be able to buy.

“The drugs themselves seem to be excellent, but Wegovy is expensive, and there are likely to be others,” Stephan Guyenet, a researcher in neuroscience and obesity, told Gizmodo.

“This is especially true in the United States, where Wegovy costs about four times more than in other countries. So the main issue is access.”

Aside from the economy, the impressive results of these drugs, however, suggest that we could soon change the treatment of obesity – a complex and harmful epidemic that has resisted our control for decades.

If we can deliver on that promise and ensure equal access to this new generation of obesity drugs, we can improve the health of millions of people around the world, researchers say.

“This is extremely exciting, although preliminary data show weight loss at the level of bariatric surgery with the help of a drug, which probably provides a number of other metabolic benefits,” Scott Kahan, director of the National Center for Weight and Welfare in Washington, DC, told Healio. .

“The continued development of tirzepatide and similar agents could signal a marine change in the treatment of obesity, much like the treatment of cholesterol and heart disease has been transformed by the advent of statins and how the treatment of HIV has been transformed by antiretroviral drugs.”

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