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Liraglutide Not Yet Approved in U.S.

Oct. 22, 2009 -- The injectable diabetes drug liraglutide appears to help obese people who do not have diabetes shed extra pounds, but larger studies are needed to prove its safety and effectiveness for weight loss, researchers say.

Liraglutide has been approved for the treatment of type 2 diabetes in Europe, but it is not yet approved for use in the United States.

In earlier studies, diabetes patients who received once-daily injections of the drug lost weight and showed improvements in blood sugar.

In the newly published study, overweight people without diabetes who received daily injections of liraglutide lost more weight than patients treated with the oral weight loss drugorlistat, sold as Xenical and Alli in the U.S.

Liraglutide belongs to the same class of drugs as the diabetes treatment Byetta, which has also been shown to promote weight loss.

The mechanism by which the drugs affect weight is not completely understood, but they are believed to suppress appetite and delay the movement of food from the stomach to the small intestine. The thinking is that this helps people feel full longer after eating.

Liraglutide and Weight Loss

The 20-week weight loss study included 564 obese people with body mass indexes (BMI) of between 30 and 40, treated at 19 sites throughout Europe.

Participants received either daily injections of one of four doses of liraglutide, injections of an inactive placebo, or the weight loss drug orlistat taken orally three times a day.

All the study participants followed calorie-restricted diets, which contained about 500 fewer calories a day than they needed to maintain their weight. They also increased their physical activity.

By the end of the study, the liraglutide-treated patients had lost significantly more weight than either the placebo-treated patients or those who took the oral weight loss drug.

Orlistat-treated patients lost an average of 9 pounds during the 20-week study, compared to a weight loss of 10.5 pounds in patients on the lowest dose of liraglutide (1.2 milligrams a day).

Patients treated with the highest dose of the liraglutide (3 milligrams daily) lost the most weight, averaging nearly 16 pounds. These patients also had the most nausea and vomiting, with 3.5% of participants withdrawing from the study as a result of these side effects.

Placebo-treated patients lost the least amount of weight -- about 6 pounds.

The study was paid for by liraglutide manufacturer Novo Nordisk, which has also provided independent financial support to several study authors.

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