Early Response to Saxenda(R) Resulted in Weight Maintenance and Additional Weight Loss Over 56 Weeks
PORTO, Portugal, May 18, 2017 /PRNewswire=KYODO JBN/ --
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(R) (liraglutide 3 mg)
or placebo. After 16 weeks of treatment with Saxenda(R), 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(R) treatment ('early non-responders').
"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(R) are able to both maintain and achieve
additional weight loss".
Of those who completed 56 weeks of treatment with Saxenda(R), 68% were
early responders to Saxenda(R) 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
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 (R), compared with 3.9% of early
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(R) was generally well-tolerated, with observed side effects
in line with previous trials.
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
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 with obesity.
Saxenda(R) (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(R) 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(R) stimulates insulin secretion and lowers glucagon secretion in a
glucose-dependent manner. Saxenda(R) was evaluated in the SCALE (Satiety and
Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.
In the EU, Saxenda(R) 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 greater than or equal to30 kg/m2 (obese), or greater than or
equal to27 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 sleep apnoea.
Guidance is given in the label that treatment with Saxenda(R) 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 greater
than or equal to30 kg/m2) or who were overweight (BMI greater than or equal
to27 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(R) (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
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
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Peter Hugreffe Ankersen
Kasper Veje (US)
Source: Novo Nordisk