Clinical Trials Experience of Liraglutide in Weight-Loss

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Liraglutide formulation was evaluated for safety in 5 double-blind, placebo controlled trials that included 3384 overweight or obese patients treated with Liraglutide formulation for a treatment period up to 56 weeks (3 trials), 52 weeks (1 trial), and 32 weeks (1 trial). All patients received study drug in addition to diet and exercise counseling. In these trials, patients received Liraglutide formulation for a mean treatment duration of 45.9 weeks (median, 55.9 weeks). Of these, 1087 Liraglutide formulation-treated patients and 497 placebo-treated patients have been exposed in their original randomized groups beyond the primary endpoint for an additional mean duration of 53.0 weeks (median, 56.9 weeks).

Baseline characteristics included a mean age of 47 years, 71% women, 85% white, 39% with hypertension, 15% with type 2 diabetes, 34% with dyslipidemia, 29% with a BMI greater than 40 kg/m2, and 9% with cardiovascular disease. Dosing was initiated and increased weekly to reach the 3 mg dose.

In clinical trials, 9.8% of patients treated with Liraglutide formulation and 4.3% of patients treated with placebo prematurely discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were nausea (2.9% versus 0.2% for Liraglutide formulation and placebo, respectively), vomiting (1.7% versus less than 0.1%), and diarrhea (1.4% versus 0%).

Adverse reactions reported in greater than or equal to 2% of Liraglutide formulation-treated patients and more frequently than in placebo-treated patients are shown in Table 3.