Newly approved Diabetes Drug delivers record weight loss in clinical trials

(ORDO NEWS) — A newly approved diabetes drug that is being clinically studied for effects on body weight in obese and overweight people provided “significant and sustained weight loss” in a Phase 3 clinical trial, according to results published in The New England Journal. of medicine.

Tirzepatide, developed by American pharmaceutical company Eli Lilly and Company (Lilly), is a once-weekly injection under the skin originally developed for the treatment of type 2 diabetes.

Although the drug is not yet indicated for this use, it also appears to promote weight loss by mimicking the action of natural hormones called incretins. These hormones lower blood sugar levels after meals and also regulate metabolic processes associated with digestion.

The latest clinical study data was originally published by Lilly at the end of April, but has now been presented in more detail at an American Diabetes Association symposium and peer-reviewed.

According to the researchers, bariatric surgery “results in about 25-30 percent weight loss over 1-2 years,” while in the current study, just over 36 percent of participants who received 15 mg of the drug achieved a 25 percent or more weight loss. more, which makes the effect of the drug similar to the results of invasive surgery.

Tirzepatide, sold under the name Munjaro, was approved by the FDA for the treatment of type 2 diabetes on May 13 this year; the drug is a synthetic combination of two specific incretins called GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).

The first hormone, GLP-1, is at the core of the antidiabetic drug semaglutide, which was approved in the US as a weight loss drug in 2021, the first FDA approval of a new weight loss drug in years.

This approval came on the basis of results that have been called “watershed” for weight loss, but it looks like the tirzepatide formula – thanks to the addition of GIP along with GLP-1 – could improve things even further.

Investigators included 2539 overweight or obese participants (with one weight-related comorbidity but no type 2 diabetes) in the Phase 3 SURMOUNT-1 clinical trial investigating the effects of tirzepatide.

Participants received tirzepatide or placebo for 72 weeks, as well as support for a low-calorie diet and increased physical activity.

Tirzepatide was administered at one of three different doses (5, 10, or 15 milligrams per weekly injection), but all three groups experienced significant weight loss during the study.

At the highest dose (15 mg), participants lost an average of 22.5% of their body weight (24 kg or 52 lb), at 10 mg they lost 21.4% (22 kg or 49 lb), and at 5 mg, weight was reduced by 16% (16 kg or 35 lbs).

In comparison, the placebo group lost only 2.4 percent of their body weight (2 kg or 5 pounds). Previously, in semaglutide weight loss trials, the average weight loss was about 17 percent.

“Tirzepatide is the first investigational drug to achieve, on average, more than a 20 percent weight loss in a phase 3 study,” said clinician Jeff Emmick, vice president of product development at Lilly.

The study in the SURMOUNT-1 trial is ongoing, along with the related SURMOUNT trials, the results of which are expected to be announced in 2023.

However, we already know that tirzepatide is not suitable for everyone who takes it. Although the average weight loss results are slightly superior to those of semaglutide treatment and are about on par with the weight loss that patients can expect from bariatric surgery, side effects were observed in some participants in the tirzepatide study.

Depending on the dose, up to a third of the tirzepatide group experienced nausea, and diarrhea was also relatively common (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 left the study due to these effects.

Another potential barrier to taking tirzepatide is the issue of price – provided that the results of subsequent studies convince the FDA to approve this drug for patients who want to lose weight.

As others have pointed out, semaglutide – marketed by the Danish pharmaceutical company Novo Nordisk under the brand name Wegovy as a weight loss drug – sells for more than US$1,300 a month, and very few patients can afford such an expensive drug, especially when such drugs are rarely covered by medical insurance. insurance.

At the end of May, a Lilly spokesperson confirmed that Mounjaro would cost $974.33 per week, regardless of dosage. As is the case with other brilliant, potentially life-changing drugs, the issue of access is once again becoming very relevant.

Economics aside, the impressive results from drugs like tirzepatide suggest that we may soon be able to change the treatment of obesity, a complex and harmful epidemic that has eluded us for decades.

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

“Further development of tirzepatide and similar drugs may herald a sea change in the treatment of obesity,” Scott Kahan, director of the National Center for Weight and Health in Washington, told Healio in May.

“Just as the treatment of cholesterol and heart disease has changed with the advent of statins, and the treatment of HIV has changed with the advent of antiretrovirals.”

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