Novo Nordisk A/S Announces Results from Phase 3a Clinical Trial for Liraglutide
Novo Nordisk A/S announced the headline results from a 56-week, double-blind phase 3a clinical trial investigating the potential of liraglutide to induce and maintain weight loss in overweight or obese people with type 2 diabetes. This is the second phase 3a trial to be completed as part of SCALETM, the clinical development program for liraglutide 3 mg as an obesity treatment. In the trial, 846 overweight or obese people with type 2 diabetes were randomized 2:1:1 to treatment with liraglutide 3 mg, liraglutide 1.8 mg or placebo. After 56 weeks, treatment was discontinued and the subjects were followed during a 12-week observational period. From a mean baseline weight of approximately 106 kg and a BMI of 37, the weight loss for people treated with liraglutide 3 mg and liraglutide 1.8 mg after 56 weeks were 6% and 5%, respectively compared to a 2% weight loss for people treated with placebo. The proportion of people achieving a weight loss of at least 5% or 10% was 50% and 22% for liraglutide 3 mg, 35% and 13% for liraglutide 1.8 mg, and 13% and 4% for placebo treatment. During the 12- week follow-up period after treatment discontinuation, people in both liraglutide treatment groups experienced a moderate weight regain. Starting from a baseline HbA1C of 8.0%, approximately 69%, 67% and 27% of people treated with liraglutide 3 mg, liraglutide 1.8 mg and placebo achieved the HbA1c treatment target of 7%.
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