Health

FDA-approved diabetes drug leads to record-breaking weight loss

By FactsWow Team

Posted on: 09 Jun, 2022

According to reports from the FDA, obese people with type 2 diabetes (T2D) who take a drug once a week have lost more than 20 percent of their body weight.

Researchers from Yale University conducted the SURMOUNT-1 study, a Phase 3 trial to test tirzepatide's efficacy and safety. On average, obese participants who took the drug at a dosage of 15 mg had a weight reduction of 22.5 percent by the 72nd week.

GLP-1 and GIP are activated by the drug; GLP-1 increases insulin production and lowers elevated blood sugars - a hallmark of T2D - and GIP increases insulin production while inhibiting gastric motility, thereby causing food to stay in the digestive system for longer periods.

It is widely believed that the most effective way to lose weight is by undergoing bariatric surgery which is widely believed to lead to the greatest weight loss of between 25 percent and 30 percent.

Patients on the 5 mg dose saw a weight reduction of 16 percent, while the group on the 10 mg dose saw a reduction of 21.4 percent. Treatment with all three doses of the drug led to significant and sustained body weight loss.

A weight loss of 5 percent was achieved in 89 percent of patients on the low dose and 96 percent on the higher dose, compared to 28 percent of patients on the placebo.

It is remarkable that in this trial, the majority of participants receiving 10-mg or 15-mg doses of tirzepatide achieved that benchmark,' wrote the authors. 'This demonstrates tirzepatide's superiority.'

Across two primary endpoints, researchers observed an overall weight reduction of more than 5 percent; the body's baseline weight and its actual weight.

The most common side effects were gastrointestinal and included nausea, vomiting, and diarrhea. These symptoms generally occurred during the dose-escalation period.

During dose-escalation, participants were given 2.5 mg in the first week and 2.5 mg every four weeks until they reached the maximum dosage allowed for their group.

The clinical studies also indicate that some participants experienced severe allergic reactions, hypoglycemia, pancreatitis, and gallbladder disease.

Dietitians or qualified health care professionals provided regular lifestyle counseling sessions to help participants follow a healthy, balanced diet, a deficit of 500 calories per day, and at least 150 minutes of physical activity each week as part of the lifestyle intervention.

Tirzepatide, branded as Mounjaro, was approved by the FDA on March 13, 2022, as a diabetes drug. However, it has not yet been approved for weight loss.

In a report by Medscape, the company marketing the drug stated that Lilly will price it at $974.33 for four weekly doses, regardless of size, which equates to about $12,666 per year. The study was presented at the American Diabetes Association Scientific Sessions in New Orleans on June 4.

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