Porto, Portugal (ots/PRNewswire) - Abstract# RS3:3
Today, results from a post hoc analysis of data from the SCALE
Maintenance trial were presented at the 24th European Congress on
Obesity (ECO) 2017. In the trial, adults who lost at least 5% of
their initial weight during a low- calorie run-in period were
randomised to receive Saxenda® (liraglutide 3 mg) or placebo. After
16 weeks of treatment with Saxenda®, participants who lost an
additional 5% or more of their body weight (defined as 'early
responders') were more likely to maintain weight loss and achieve
greater additional weight loss over 56 weeks, compared with people
losing less than 5% body weight after 16 weeks of Saxenda® treatment
"In the obesity specialist setting, low-calorie diets combined with
increased physical activity are commonly used to induce an initial
weight loss in people with obesity. However, when the initial weight
loss reaches a plateau and patients enter the 'weight maintenance
phase' with less stringent caloric restriction, we often see that
many experience weight regain," said Dr Sean Wharton, medical
director at the Wharton Medical Clinic, Ontario and SCALE clinical
trial investigator. "As a consequence, pharmacotherapy can be used to
help people with obesity in maintaining the weight loss that has
already been achieved by a low-calorie diet and increased physical
activity. These data are very encouraging to clinicians in this
specialist setting, because they show that early responders to
Saxenda® are able to both maintain and achieve additional weight
Of those who completed 56 weeks of treatment with Saxenda®, 68% were
early responders to Saxenda® at week 16 and 32% were early
non-responders. In addition to weight loss achieved during the run-in
period, early responders experienced 9.9% weight loss, compared with
0.0% in early non-responders at 56 weeks.
Following 56 weeks of treatment, 91.7% of early responders and 47.1%
of early non-responders, had maintained or lost additional weight
following the run-in period. No early responders regained their
run-in weight loss over 56 weeks of treatment with Saxenda®, compared
with 3.9% of early non-responders.
There were similar incidences of total adverse events in early
responders (92.7%) and early non-responders (91.0%). Gastrointestinal
adverse events were more frequent in early responders compared with
early non-responders (78.9% vs 62.7%). Saxenda® was generally
well-tolerated, with observed side effects in line with previous
Obesity is a disease,that requires long-term management. It is
associated with many serious health consequences and decreased life
expectancy., Obesity-related comorbidities include type 2
diabetes, heart disease, obstructive sleep apnoea (OSA) and certain
types of cancer.,,It is a complex and multi-factorial
disease that is influenced by physiological, psychological,
environmental, socio-economic and genetic factors.
The global increase in the prevalence of obesity is a public health
issue that has severe cost implications to healthcare systems. In
2014, 13% of adults, or approximately 600 million adults, were living
Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like peptide-1
(GLP-1) analogue with 97% similarity to naturally occurring human
GLP-1, a hormone that is released in response to food intake.
Like human GLP-1, Saxenda® regulates appetite by increasing feelings
of fullness and satiety, while lowering feelings of hunger and
prospective food consumption, thereby leading to reduced food intake.
As with other GLP-1 receptor agonists, Saxenda® stimulates insulin
secretion and lowers glucagon secretion in a glucose-dependent
manner. Saxenda® was evaluated in the SCALE (Satiety and Clinical
Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.
In the EU, Saxenda® is indicated as an adjunct to a reduced-calorie
diet and increased physical activity for weight management in adult
patients with an initial BMI of >=30 kg/m2 (obese), or >=27
kg/m2 to <30 kg/m2 (overweight) in the presence of at least one
weight-related comorbidity such as dysglycaemia (prediabetes or type
2 diabetes mellitus), hypertension, dyslipidaemia or obstructive
Guidance is given in the label that treatment with Saxenda® should be
discontinued after 12 weeks on the liraglutide 3.0 mg/day dose, if
patients have not lost at least 5% of their initial body weight.
About the SCALE Maintenance clinical trial
In the SCALE Maintenance clinical trial, adults with obesity (BMI
>=30 kg/m2) or who were overweight (BMI >=27 kg/m2 to <30
kg/m2) with comorbidities (dyslipidaemia and/or hypertension), who
lost at least 5% of their initial weight during a low-calorie diet
(1200-1400 kcal/day) run-in period, were randomised to receive
Saxenda® (n=212) or placebo (n=210) for 56 weeks, both as an adjunct
to a reduced-calorie diet and increased physical activity.
Novo Nordisk's phase 3 development programme, called SCALE,
investigated liraglutide 3 mg for weight management. The SCALE
clinical development programme consisted of four, placebo-controlled,
multinational trials called: SCALE Obesity and Prediabetes, SCALE
Diabetes, SCALE Sleep Apnoea and SCALE Maintenance.[12-16]
Novo Nordisk is a global healthcare company with more than 90 years
of innovation and leadership in diabetes care. This heritage has
given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth
disorders and obesity. Headquartered in Denmark, Novo Nordisk employs
approximately 42,000 people in 77 countries and markets its products
in more than 165 countries. For more information, visit
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Peter Hugreffe Ankersen
Kasper Veje (US)
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