Memorandum

Three-year results from SCALE Obesity and Prediabetes Extension Trial show Novo Nordisk’s Saxenda (liraglutide 3.0 mg) reduced risk of developing type 2 diabetes – May 27, 2015

Last Friday, Novo Nordisk announced topline results from the SCALE Obesity and Prediabetes three-year extension trial, showing that treatment with Saxenda (liraglutide 3.0 mg) reduced the risk of developing type 2 diabetes by ~80% (p<0.0001) compared to placebo. Results of the 160-week, randomized, blinded phase 3a trial also found that the time to onset of type 2 diabetes was 2.6 times longer with Saxenda vs. placebo. Regarding weight loss, at 160 weeks, those on Saxenda experienced a mean weight loss of 6% vs. 2% on placebo. The proportion that achieved ≥5% weight loss was 50% with Saxenda vs. 23% with placebo; and the proportion that achieved ≥10% weight loss was 24% with Saxenda vs. 9% with placebo. In addition, the completion rate for 160 weeks was 53% and 45% for the Saxenda and placebo groups, respectively. As expected, no new safety issues were identified, with the most common adverse events being GI;, withdrawals due to adverse events were 13% with Saxenda and 6% with placebo. While these weight loss findings for Saxenda were slightly less impressive than those at 56 weeks (8% weight loss; 63% and 33% achieve ≥5% and ≥10% weight loss, respectively), there was still a significant and very impressive degree of weight maintenance at three years. Additionally, with the rise in obesity, approaches where ~20% of patients are super responders are still significant in terms of the sheer number of patients that could be helped. These results also strengthen the trial’s 56-week results of Saxenda reducing the risk of type 2 diabetes by ~65%, and are indicative of the benefits of chronic use. We hope that these longer-term results provide more support for the consideration of a prediabetes indication or at least get the field thinking more about the role of pharmacotherapies’ in prevention of type 2 diabetes. For more background on SCALE Obesity and Prediabetes, please see our coverage of the trial from ICE/ENDO, EASD, Obesity Week, and ECO.