Novo Nordisk has presented new findings from the STEP UP Phase IIIb trial investigating the effects of two different dosages of its obesity drug, Wegovy, on weight loss.
The pharma manufacturer presented the findings at ObesityWeek, taking place on 4-7 November in Atlanta, US.
It showed that, in addition to losing an average of 21% of their body weight, Wegovy (the approved semaglutide 2.4 mg dose and investigational higher 7.2 mg dose) enables people with obesity to achieve treatment targets associated with a low risk of obesity-related complications.
There are no set guidelines for treatment guidelines for obesity, unlike many other diseases.
Outcomes often rely on percentage weight loss, in conjunction with body mass index (BMI) calculations and waist-to-height ratio (a measurement of unhealthy waist size).
A primary consideration in the management of obesity should also be the prevention of obesity-related complications, such as cardiovascular, kidney and liver diseases, alongside weight loss.
In the STEP UP sub-analysis, more people with obesity who received Wegovy achieved the target BMI of less than 27 and a waist-to-height ratio of less than 0.53 (19.5% for semaglutide 7.2 mg and 13.2% for semaglutide 2.4 mg) compared to placebo (0%).
People treated with Wegovy who achieved both treatment targets reached healthy levels for two or more cardiovascular risk factors, including blood pressure, cholesterol and blood sugar levels.
“These new results demonstrate that most people on Wegovy who achieve certain BMI and waist targets also benefit when it comes to lowering their cardiovascular risk factors,” said Emil Kongshøj Larsen, Executive Vice President and Head of International Operations at Novo Nordisk.
”This shows the efficacy of Wegovy in not only helping people lose excess weight but also preventing obesity-related complications and improving overall health."
"The risk of developing serious complications such as cardiovascular, kidney and liver diseases increases for people living with overweight or obesity."
"The STEP UP trial has also shown that a higher dose of Wegovy delivers an average weight loss of 21%, with one in three people achieving weight loss of 25% or more and will offer a significant new option to help people with obesity achieve their weight and health goals.”
All participants who achieved both BMI and waist-to-height ratio targets also reached healthy levels for two or more cardiovascular risk factors.
More than half reached healthy levels for all four risk factors, indicating a low risk of cardiovascular disease for those treated with Wegovy.
The results support the use of these BMI and waist-to-height ratio treatment targets in managing obesity and reiterate that Wegovy can lower the risk of obesity-related complications, alongside its proven weight loss effect.
“The use of BMI and waist-to-height ratio targets has been shown to be associated with a lower risk of obesity-related complications,” said Carel le Roux, University College Dublin, Ireland.
“This new STEP UP analysis reinforces the health benefits we have come to expect of semaglutide, such as cardiovascular protection, demonstrating its power in helping people with the disease of obesity achieve meaningful weight loss and health gains.”
The new, higher dose of Wegovy (semaglutide 7.2 mg), investigated in two STEP UP trials, is currently under review with the European Medicines Agency (EMA) in the UK and several other countries.
In the EU, Novo Nordisk expects a regulatory decision around the turn of the year. Novo Nordisk also expects to submit to the US Food and Drug Administration.