Patients lost an average of 6% of body weight after one year
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Liraglutide, a drug marketed as Victoza for diabetes and recently approved for weight-loss under the brand name Saxenda, helped overweight and obese patients with type 2 diabetes lose weight, researchers reported in the August 18 issue of the Journal of the American Medical Association.
After about a year of once-daily injections with liraglutide 3 mg, patients lost an average of 6.4 kg from baseline compared to 2.2 kg in a placebo group, said lead investigator Melanie Davies, MD, of the University of Leicester in the United Kingdom, and colleagues.
"The strength of this study is that it's a first major international trial looking at the dose of 3.0 mg of liraglutide specifically for weight loss in patients with diabetes, and thus provides us with evidence in this group," Davies told MedPage Today via email.
Liraglutide 3 mg was approved by the U.S. Food and Drug Administration last December for weight loss in adults with a body mass index (BMI) of 30 kg/m2 or higher, or with a BMI of 27 kg/m2 or higher and at least one weight-related medical condition.
Previously, liraglutide was approved for treating type 2 diabetes at doses of 1.8 mg and 1.2 mg. The drug belongs to a class known as glucagon-like receptor 1 (GLP-1) agonists.
The study included 846 adult patients with type 2 diabetes and a BMI of 27 kg/m2 or higher. These were randomized to once-daily injections of liraglutide 3 mg (n=423), liraglutide 1.8 mg (n=211), or placebo (n=212).
Participants were encouraged to follow a diet with a 500/kcal-day energy deficit and an exercise program of 150 minutes or more of brisk walking per week. They were followed for 56 weeks.
Mean weight loss was 6% (6.4 kg) in the liraglutide 3 mg group and 4.7% (5.0 kg) in the liraglutide 1.8 mg group compared with 2% (2.2 kg) in the placebo group (P<0.001 for both comparisons).
Approximately 54% of the 3 mg group and 40% of the 1.8 mg group lost 5% or more of baseline body weight, compared with 21% in the placebo group (P<0.001 for both comparisons).
Slightly more than 25% of the 3 mg group and about 16% of the 1.8 mg group lost 10% or more of baseline body weight, compared with 6.7% in the placebo group (P<0.001 for liraglutide 3 mg versus placebo; P=0.006 for liraglutide 1.8 mg versus placebo).
Gastrointestinal adverse events, including nausea, vomiting, diarrhea, and constipation were the most frequently reported, with more of these events occurring in the liraglutide 3 mg group compared with the 1.8 mg group. The rate of serious adverse events was 8.8% in the 3 mg group, 8.6% in the 1.8 mg group, and 6.1% in the placebo group.
No cases of pancreatitis were reported, which has been a safety concernfor GLP-1 agonists.
However, "the study was not powered to enable definitive conclusions about safety to be made," the investigators said.
Study participants regained weight after liraglutide was discontinued, "indicating that continued treatment is necessary to sustain the on-drug benefits," the investigators noted. Further studies will be needed to assess the long-term effects of liraglutide, they said.
"The limitations are probably that the study is only a year and that we need to look at longer term follow up," Davies told MedPage Today. "And we perhaps in the future would want to look at more intensive lifestyle interventions in combinations with liraglutide."
When to Consider Weight-Loss Drugs?
In addition to liraglutide, four other weight-loss drugs have been approved since 2010. These drugs should not be used as a substitute for diet and exercise, but they may be useful in helping some patients stick to their diet, said Nikhil Dhurandhar, PhD, president of The Obesity Society.
"It is very hard to eat less than what your body requires," Dhurandhar told MedPage Today. "If you deprive your body of food, it goes into a kind of 'panic mode.' There are so many physiological and psychological mechanisms geared toward making you eat. So long-term compliance with a weight-loss diet is really challenging."
"If a patient tells you 'I understand what I'm supposed to do, but sometimes I'm not able to do it. I give in,' this is a person who may benefit from some sort of help," Dhurandhar said.
"Weight-loss drugs can empower you to say no and increase your resolution," he said.
However, Dhurandhar cautioned that pharmacotherapy options for weight loss are limited and still not well understood. In addition, as with any drug, individual patient response is likely to vary considerably. "There is no one drug that will work for everybody," he said.
Dhurandhar was not involved in the liraglutide study. However he has served as a speaker and consultant for Novo Nordisk, the drug's manufacturer.
This research was funded by Novo Nordisk.
Melanie Davies and the other study authors reported financial relationships with a large number of commercial entities, including Novo Nordisk, Boehringer Ingelheim, Sanofi, Eli Lilly, Merck Sharpe & Dohme, AstraZeneca, Novartis, GlaxoSmithKline, and Janssen.
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