The Lancet has published the results of a study that aimed to assess the efficacy and tolerability of liraglutide in the treatment of obesity in individuals without type 2 diabetes. This study has been reported in the general media (BBC).
The study recruited men and women aged 18 to 65 years old with a body mass index (BMI) of 30-40kg/m2. Patients with type1 or type 2 diabetes and those with a fasting glucose of 7mmol/L or above were excluded. Participants were then randomly assigned to a placebo injection, one of four dose regimens of liraglutide (1.2mg, 1.8mg, 2.4mg or 3.0mg daily) or open-label orlistat. Follow up was for 20 weeks in total which included a 4 week titration phase and 16 weeks of stable dosing. All participants were also advised regarding a 500 kcal per day energy-deficient diet and increased their physical activity throughout the trial.
Mean body weight, waist size and blood pressure were reduced in all groups. Liraglutide produced significantly greater reductions in body weight compared to placebo at all doses and at the two higher doses when compared to orlistat. Participants on the higher dose of liraglutide (3.0mg daily) lost an average of 7.2kg over the 20 week study.
Nausea and vomiting occurred much more frequently with liraglutide therapy and these side effects were also dose related. 5.1% of patients on the placebo injection experienced nausea compared to 24.2% to 47.3% of patients on liraglutide.
The authors note that the open label orlistat treatment and the different injection volumes of the daily doses of liraglutide may introduce some bias. They also note that the long-term effects of this treatment on body weight, lipids, cardiovascular risk and mortality need to be assessed in longer studies.
The authors conclude that, "the results of this study indicate the potential benefit of liraglutide" but also suggest that "the long-term risk–benefit profile for liraglutide, as well as its weight maintenance capabilities, remain to be established". In addition, patient acceptability of an injectable therapy to aid weight loss remains unknown.
Action: Clinicians should be aware of the results of this study. Liraglutide is not currently licensed as a weight management product. Use of this drug in patients without diabetes, with the aim of aiding weight loss, should be avoided pending further research and a license for this indication.