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2021-11-07| Trials & Approvals

Novo Nordisk’s Weight Loss Drug Shines in Phase 3 Trial

by Rajaneesh K. Gopinath
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Obesity is a rising global epidemic that has grown with sedentary lifestyles. The chronic disease requires long-term management and is associated with many serious health complications, including type 2 diabetes, heart disease, obstructive sleep apnea, and certain types of cancer.

In June this year, Novo Nordisk’s Wegovy (semaglutide 2.4 mg injection), which was found to be very effective in a clinical trial, was granted FDA approval for treating adults with obesity. On November 5th, the Danish drug manufacturer presented encouraging results from the STEP 5 phase 3b trial at the ObesityWeek 2021 interactive congress.

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The 304 participant trial investigated Wegovy vs. placebo, both used with a reduced-calorie meal plan and increased physical activity for the treatment of obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/ m2) for 104 weeks (two years). Results showed that adults treated with Wegovy achieved significant and sustained weight loss over the two-year study period.

“With current obesity treatments, we tend to see a waning of the weight-lowering effects of the treatment over time. We set out to investigate if that would hold true also for semaglutide 2.4 mg. It is very encouraging for us to see that even after two years of treatment with semaglutide 2.4 mg, we still see a significant and sustained weight loss of 15%,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk

We are very pleased with the promise these findings offer to people living with obesity. For many people, maintaining an achieved weight loss over time is an equally big challenge as achieving the weight loss in the first place.”

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Significant Weight Loss

Semaglutide is an analog of the human glucagon-like peptide-1 (GLP-1) hormone, with 94% similarity to the native human GLP-1 molecule. It induces weight loss by reducing hunger, increasing satiety, and thereby reducing food cravings.

The STEP 5 trial demonstrated an average weight loss of 15.2% with Wegovy at 104-weeks when used with a reduced-calorie meal plan and increased physical activity vs. 2.6% with placebo. The study also showed that 77.1% of study participants who received the drug lost at least 5% of their body weight, compared to 34.4% of those who received the placebo.

“People with obesity try on average seven times to lose weight before seeking medical care. Once the weight is lost, however, it all too often comes back, which is why it is critically important to find options to help people living with obesity lose weight and keep it off,” said W. Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham.

“Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight whilst taking Wegovy™ and maintain the weight loss at two years, which can help us better treat and manage obesity as a chronic disease.”

Based on 68-week trials, the most frequently reported side effects with Wegovy were nausea, diarrhea, vomiting, constipation, and abdominal pain.

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