In an effort to increase Wegovy’s (semaglutide) prominence, Novo Nordisk has released results from a Phase IIIb STEP UP trial showing that weekly high dose (7.2mg) subcutaneous semaglutide can achieve higher average weight loss than the approved low dose (2.4mg) version.
The Danish company noted that the Phase IIIb STEP UP study (NCT05646706) met its primary endpoint by demonstrating a “statistically significant and superior” weight loss at week 72 with a high dose of Wegovy compared to placebo.
Phase IIIb STEP UP trial results
The Phase IIIb trial enrolled 1,407 adults with obesity and a mean baseline body weight of 113 kg. The participants received either of the two doses of Wegovy or a placebo in addition to lifestyle intervention. Novo Nordisk reported 20.7% weight loss after 72 weeks with high-dose semaglutide, compared to 17.5% and 2.4% seen in the low-dose Wegovy and placebo groups respectively.
When considering weight loss regardless of treatment adherence, the mean weight loss dropped to 18.7% with high-dose semaglutide, compared to 15.6% and 3.9% seen in the low-dose Wegovy and placebo arms respectively.
Additionally, 33.2% of the participants in the high-dose semaglutide group achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with low-dose Wegovy and 0% with placebo. Furthermore, Novo Nordisk noted that the high dose of semaglutide had a safe and well-tolerated profile.
Trouble brewing on the horizon
The impressive weight loss results were not enough to stop the decline of Novo Nordisk’s stock, which fell by 5.27% at the market close on 17 January (when the results were released) compared to the market close on the previous day.
Novo Nordisk’s obesity drugs have faced stiff competition from Eli Lilly’s glucagon-like peptide-1 (GLP-1) counterpart Zepbound (tirzepatide) in recent months. Novo Nordisk’s obesity drugs, Wegovy and Saxenda (liraglutide) raked in 43,740 million DKK (approx. $6 billion) in worldwide sales in the first nine months of 2024, compared to Zepbound which generated $3 billion in global sales during the same period, as per the respective companies’ financials.
Although Novo Nordisk enjoys the first-to-market advantage with its semaglutide versions. Last month, Lilly released data from an open-label Phase IIIb SURMOUNT-5 (NCT05822830) that compared its weight loss drug with Wegovy. The study reported a 47% greater relative weight loss with Zepbound compared to Wegovy. Lilly also boasted that at 72 weeks, its GLP-1 therapy beat Novo Nordisk’s on both the primary endpoint and all five key secondary endpoints in the study.
