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In a 56-week study, adult patients with obesity or overweight with ≥ 1 weight-related comorbidity (without type 2 diabetes) achieved:

Superior weight loss with Saxenda® (vs. placebo1)

 

Change in body weight from baseline
Graph Change in body weight from baseline

Adapted from Saxenda® Product Monograph, 20221

64% of patients on Saxenda® (n = 2437) lost ≥ 5% vs. 27% with placebo (n = 1225)
(P < 0.0001; OR: 4.8)
33% of patients on Saxenda® (n = 2437) lost > 10% vs. 10% with placebo (n = 1225)
(P < 0.0001; OR: 4.3)

OR = odds ratio.
Baseline mean body weight values: 106.3 kg (234.4 lb) for the Saxenda® group and placebo group.

Patients treated with Saxenda® (n = 2437) experienced an observed mean waist circumference change of -8.2 cm vs. -4.0 cm with placebo (n = 1225) (2° endpoint)
Baseline waist circumference values: 115 cm for the Saxenda® group vs. 114.5 cm for placebo.
In a 160-week study, a subset of patients who had abnormal glucose measurement at randomization experienced a:

6.2% change in body weight with Saxenda® (vs. 1.8% with placebo)1*

50% of patients randomized to Saxenda® (747 of 1472) and 43% treated with placebo (322 of 738) completed their
160-week weight assessment.

* Baseline values: mean body weight: 107.6 kg (237.2 lb) for Saxenda® vs. 108 kg (238.1 lb) for placebo. Missing data were imputed using the last observation carried forward (LOCF) when calculating percent change from baseline.

In a 56-week study, adult patients with obesity or overweight with ≥ 1 weight-related comorbidity (without type 2 diabetes) experienced:

Changes in cardiometabolic parameters
with Saxenda®1

 

Photo blood glucose
BLOOD GLUCOSE LEVELS
Photo blood pressure
BLOOD PRESSURE
Photo cardio benefits
BLOOD LIPIDS
Photo blood glucose
BLOOD GLUCOSE LEVELS
Roberto photo
Photo blood pressure
BLOOD PRESSURE
Roberto photo
Photo cardio benefits
BLOOD LIPIDS
Roberto photo

Adapted from Saxenda® Product Monograph 2022.

SCALE™ Study 1 (56 week)
Close Open
Graph scale obesty 1 year
SCALE™ Study 1 (Week 160)
Close Open
Graph scale obesty 1 year

Safety and tolerability profile:

Evaluated in a robust clinical trial program including 3384 patients taking Saxenda®1
GI_Tract
  • Gastrointestinal adverse events (AEs) were the most frequently reported AEs during treatment with Saxenda® (67.9% vs. 39.3% with placebo) and were more often severe (4.8% vs. 1.4% with placebo) and led to withdrawal more often (6.2% vs. 0.8% with placebo)
GI_Tract
  • The most frequently reported gastrointestinal AEs (occurring in > 15% of Saxenda®–treated patients [n = 3384] vs. placebo [n = 1941]) were:
    • Nausea (39.3% with Saxenda® vs. 13.8% with placebo)
    • Diarrhea (20.9% with Saxenda® vs. 9.9% with placebo)
    • Constipation (19.4% with Saxenda® vs. 8.5% with placebo)
    • Vomiting (15.7% with Saxenda® vs. 3.9% with placebo)
  • Nausea was transient
    • The percentage of patients reporting nausea declined as treatment continued
GI_Tract
  • During the main treatment period of the weight management studies, serious AEs were both more common with Saxenda® (6.3% vs. 4.6%) and led to withdrawal more often (1.2% vs. 0.7%), compared to placebo.
  • In controlled clinical trials, 9.8% of patients treated with Saxenda® and 4.3% of patients treated with placebo prematurely discontinued treatment due to adverse reactions.
  • The most common adverse reactions (occurring in > 1% of Saxenda®–treated patients) leading to discontinuation were nausea (2.9% in Saxenda® vs. 0.2% in placebo), vomiting (1.7% vs. < 0.1%), and diarrhea (1.4% vs. 0%).


Other gastrointestinal events that occurred more commonly among Saxenda®–treated patients included diarrhea, constipation, vomiting, dyspepsia, abdominal pain, dry mouth, gastritis, gastroesophageal reflux disease, flatulence, eructation, abdominal distension, and headache. Most episodes of gastrointestinal events were mild or moderate and did not lead to discontinuation of therapy. There have been reports of gastrointestinal AEs, such as nausea, vomiting, and diarrhea, associated with volume depletion and renal insufficiency. Saxenda® should not be used by patients with inflammatory bowel disease or diabetic gastroparesis.
Graph Change in body weight from baseline

Learn how to help your patients get started on Saxenda®

Find out more about how Saxenda® may help your patients living with obesity or overweight

AE = adverse event; GI = gastrointestinal; LOCF = last observation carried forward.

 

References:

  1. Saxenda® Product Monograph. Novo Nordisk Canada Inc. April 24, 2024.
  2. Novo Nordisk Canada Inc. Data on File. 2015.

 

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