SAXENDA Rx

Weight Management Trials in Adults with Overweight or Obesity 

The safety and efficacy of Saxenda for chronic weight management in conjunction with reduced caloric intake and increased physical activity were studied in three 56-week, randomized, double-blind, placebo-controlled trials. In all studies, Saxenda was titrated to 3 mg daily during a 4-week period.

• Study 1 enrolled 3731 patients with obesity (BMI ≥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. Patients were randomized in a 2:1 ratio to either Saxenda or placebo. Patients were stratified based on the presence or absence of abnormal blood glucose measurements at randomization. All patients were treated for up to 56 weeks. Those patients with abnormal glucose measurements at randomization (2254 of the 3731 patients) were treated for a total of 160 weeks. Mean baseline body weight was 106.3 kg and mean BMI was 38.3 kg/m².
• 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 a reduced-calorie diet and physical activity alone. Patients were randomized in a 2:1 ratio to receive either Saxenda or placebo. Mean baseline body weight was 105.9 kg and mean BMI was 37.1 kg/m². 
• Study 3 was a 56-week trial that enrolled 422 patients with obesity (BMI ≥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. Mean baseline body weight was 99.6 kg and mean BMI was 35.6 kg/m².

For Study 1 and Study 2, the primary efficacy parameters were mean percent change in body weight and the percentages of patients achieving ≥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 (eg, after run-in) to week 56, and the percentage of patients achieving ≥5% weight loss from randomization to week 56. Because losing at least 5% of fasting body weight through lifestyle intervention during the 4- to 12-week run-in was a condition for their continued participation in the randomized treatment period, the results may not reflect those expected in the general population.

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. The following are the results observed in Studies 1, 2, and 3 at week 56 for treatment with Saxenda vs placebo, respectively:

• Study 1 (Obesity or overweight with comorbidity)
  • Weight percent change from baseline:  -7.4 vs -3.0; difference from placebo:  -4.5 (95% CI, -5.2, -3.8; P <.0001)
  • % of patients losing ≥5% body weight:  62.3% vs 34.4%; difference from placebo:  27.9 (95% CI, 23.9-31.9; P <.0001)
  • % of patients losing >10% body weight:  33.9% vs 15.4%; difference from placebo:  18.5 (95% CI, 15.2-21.7; P <.0001)
• Study 2 (Type 2 diabetes with obesity or overweight)
  • Weight percent change from baseline:  -5.4 vs -1.7; difference from placebo:  -3.7 (95% CI, -4.7, -2.7; P <.0001)
  • % of patients losing ≥5% body weight:  49.0% vs 16.4%; difference from placebo:  32.6 (95% CI, 25.1-40.1; P <.0001)
  • % of patients losing >10% body weight:  22.4% vs 5.5%; difference from placebo:  16.9 (95% CI, 11.7-22.1; P <.0001)
• Study 3 (Obesity or overweight with comorbidity following at least 5% weight loss with diet)
  • Weight percent change from baseline:  -4.9 vs -0.3; difference from placebo:  -5.2 (95% CI, -6.8, -3.5; P <.0001)
  • % of patients losing ≥5% body weight:  44.2% vs 21.7%; difference from placebo:  22.6 (95% CI, 13.9-31.3; P <.0001)
  • % of patients losing >10% body weight:  25.4% vs 6.9%; difference from placebo:  18.5 (95% CI, 11.7-25.3; P <.0001)

Weight Management Trial in Pediatric Patients Ages 12 and Older with Obesity 

Saxenda was evaluated in a 56-week, double-blind, randomized, parallel group, placebo controlled multicenter trial in 251 pubertal pediatric patients aged 12 to 17 years, with BMI corresponding to 30 kg/m² or greater for adults by international cut-off points and BMI of 95th percentile or greater for age and sex. After a 12-week lifestyle run-in period, patients were randomized 1:1 to Saxenda once-daily or placebo once-daily. The Saxenda dose was titrated to 3 mg over a 4- to 8-week period based on tolerability as judged by the investigator. Escalation of the trial product was not allowed if the subject had a self-monitored plasma glucose (SMPG) < 56 mg/dL or < 70 mg/dL in the presence of symptoms of hypoglycemia during the week prior to or during the dose escalation visits. The proportion of patients who reached the 3 mg dose was 82.4%; for 8.8% of patients 2.4 mg was the maximum tolerated dose.

The primary endpoint was change in BMI SDS. At baseline, mean BMI SDS was 3.14 in the Saxenda group and 3.20 in the placebo group. At week 56, treatment with Saxenda resulted in statistically significant reduction in BMI SDS from baseline compared to placebo. The observed mean change in BMI SDS from baseline to week 56 was -0.23 in the Saxenda group and -0.00 in the placebo group. The estimated treatment difference in BMI SDS reduction from baseline between Saxenda and placebo was -0.22 with a 95% confidence interval of -0.37, -0.08; P =0.0022.

For more clinical trial data, see full labeling.