Treatment with liraglutide, in addition to an energy-deficit diet and exercise program, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes in obese individuals, study results show.

The double-blind, placebo-controlled, 20-week trial, which also used open-label orlistat as a comparator, was carried out in 19 sites across Europe to assess the effect of the glucagon-like peptide-1 agonist liraglutide, initially developed for the treatment of Type 2 diabetes, on bodyweight.

In total, 564 obese people without Type 2 diabetes (age 18 “65 years, body-mass index 30 “40 kg/m²) were randomly assigned to receive 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg liraglutide (n=90 “95), to placebo (n=98) administered once a day subcutaneously, or to open-label active comparator orlistat (120 mg, n=95) three times a day orally. All individuals had a 500-kcal per day energy-deficit diet and increased their physical activity throughout the trial.

Arne Astrup (University of Copenhagen, Denmark) and colleagues report that participants on all doses of liraglutide lost significantly more weight than those on placebo or orlistat. Mean weight loss with liraglutide 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg was 4.8 kg, 5.5 kg, 6.3 kg, and 7.2 kg, respectively, compared with 2.8 kg with placebo and 4.1 kg with orlistat.

Liraglutide also reduced blood pressure at all doses, reduced the prevalence of prediabetes by 84-96% at 1.8 “3.0 mg per day, reduced the proportion of patients with metabolic syndrome by more than 60% at 2.4 mg and 3.0 mg per day, and reduced mean fasting plasma glucose by 7 “8% with all doses.

Of note, nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo or orlistat, but adverse events were mainly transient and rarely led to discontinuation of treatment.

“Liraglutide offers a new mode of action for the treatment of obesity and improved efficacy compared with currently available therapies,” conclude Astrup and co-authors in The Lancet.

They add: “Its effect on prediabetes suggests that it might be important for treating obese prediabetic individuals.”

However, the long-term risk “benefit profile for liraglutide, as well as its weight maintenance capabilities, remains to be established, note the researchers.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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