Saxenda (liraglutide [rDNA origin] injection)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2014

Specific Treatments:

chronic weight management

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General Information

Saxenda (liraglutide [rDNA origin] injection) is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. 

Saxenda is specifically indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g.,hypertension, type 2 diabetes mellitus, or dyslipidemia).

Saxenda is supplied as a solution for subcutaneous administration. The recommended dose of Saxenda is 3 mg daily. Administer at any time of day, without regard to the timing of meals. Dosing should be initiated at 0.6 mg per day for one week. Increase the dose in weekly intervals until a dose of 3 mg is reached. Saxenda should be injected subcutaneously in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment.

Clinical Results

FDA Approval

The FDA approval of Saxenda for chronic weight management was based on three 56-week, randomized, double-blind, placebo-controlled trials. In all studies, Saxenda was titrated to 3 mg daily during a 4-week period. All patients received instruction for a reduced calorie diet (approximately 500 kcal/day deficit) and exercise counseling (recommended increase in physical activity of minimum 150 mins/week) that began with the first dose of study medication or placebo and continued throughout the trial. Study 1 was a 56-week trial that enrolled 3,731 patients with obesity (BMI greater than or equal to 30 kg/m2) or with overweight (BMI 27-29.9 kg/m2) and at least one weight-related comorbid condition such as treated or untreated dyslipidemia or hypertension; patients with type 2 diabetes mellitus were excluded. Study 2 was a 56-week trial that enrolled 635 patients with type 2 diabetes and with either overweight or obesity (as defined above). Patients were to have an HbA1c of 7-10% and be treated with metformin, a sulfonylurea, or a glitazone as single agent or in any combination, or with diet and exercise alone. Study 3 was a 56-week trial that enrolled 422 patients with obesity (BMI greater than or equal to 30 kg/m2) or with overweight (BMI 27-29.9 kg/m2) and at least one weight-related comorbid condition such as treated or untreated dyslipidemia or hypertension; patients with type 2 diabetes mellitus were excluded. All patients were first treated with a low-calorie diet (total energy intake 1200-1400 kcal/day) in a run-in period lasting up to 12 weeks. Patients who lost at least 5% of their screening body weight after 4 to 12 weeks during the run-in were then randomized, with equal allocation, to receive either Saxenda or placebo for 56 weeks. The subjects in Studies ! and 2 also received either Saxenda or placebo for 56 weeks. The proportions of patients who discontinued study drug in the 56-week trials were 27% for the Saxenda-treated group and 35% for the placebo-treated group. Approximately 10% of patients treated with Saxenda and 4% of patients treated with placebo discontinued treatment due to an adverse reaction.

Study Results:

For Study 1 and Study 2, the primary efficacy parameters were mean percent change in body weight and the percentages of patients achieving greater than or equal to 5% and 10% weight loss from baseline to week 56. For Study 3, the primary efficacy parameters were mean percent change in body weight from randomization to week 56, the percentage of patients not gaining more than 0.5% body weight from randomization to week 56, and the percentage of patients achieving greater than or equal to 5% weight loss from randomization to week 56. After 56 weeks, treatment with Saxenda resulted in a statistically significant reduction in weight compared with placebo. Statistically significantly greater proportions of patients treated with Saxenda achieved 5% and 10% weight loss than those treated with placebo. In Study 3, statistically significantly more patients randomized to Saxenda than placebo had not gained more than 0.5% of body weight from randomization to week 56. 

Side Effects

Adverse effects associated with the use of Saxenda may include, but are not limited to, the following:

  • nausea
  • hypoglycemia
  • diarrhea
  • constipation
  • vomiting
  • headache
  • decreased appetite
  • dyspepsia
  • fatigue
  • dizziness
  • abdominal pain
  • increased lipase

Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Mechanism of Action

Saxenda is an acylated human glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats. 

Additional Information

For additional information regarding Saxenda or chronic weight management, please visit http://www.saxenda.com/