GLP-1 Receptor Agonist Approved for Weight Control

January 20, 2015

Liraglutide 3 mg (Saxenda) is approved for use in adults with BMI >30 or with BMI >27 and one significant obesity-related condition.

The FDA has approved the GLP-1 receptor agonist liraglutide (Saxenda, [liraglutide (rDNA origin) injection] Novo Nordisk) for the treatment of chronic weight management in combination with a reduced-calorie diet and physical activity.

Liraglutide is also used in the treatment of type 2 diabetes mellitus and was approved in 2010 under the brand name Victoza. Although Saxenda and Victoza have the same active ingredient, Saxenda contains almost double the dose (3 mg vs 1.8 mg).

With this new approval, liraglutide 3 mg can be used in adults with a BMI of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition, such as hypertension, type 2 diabetes mellitus, or hyperlipidemia.  

Liraglutide 3 mg was approved based on the results of 3 clinical trials including approximately 4800 obese and overweight patients with and without significant weight-related conditions. Results of the largest trial, the SCALE trial, were presented in May 2014 at the America Association of Clinical Endocrinologists.

In this phase 3a trial, 3731 patients were randomly assigned to liraglutide 3 mg or placebo in combination with diet and exercise. Patients assigned to liraglutide 3 mg had a weight loss of about 8% from baseline compared with 2.6% with placebo (P<.0001). Sixty-four percent of patients assigned liraglutide 3 mg achieved a weight loss of 5% or more compared with 27% of patients in the placebo group (P<.0001).  

According to the FDA, liraglutide 3 mg should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes mellitus.

The FDA approved liraglutide 3 mg with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with liraglutide 3 mg.

See manufacturer’s full prescribing information for details on adverse effects, contraindications and dosing information.