About one third (35 percent) of people who took a new drug for treating obesity lost more than one-fifth of their total body weight, according to a major global study.
From: University College London
February 11, 2021 -- The findings from
the large-scale international trial, published today in the New England Journal
for Medicine, are being hailed as a "gamechanger" for improving the
health of people with obesity and could play a major part in helping the UK to
reduce the impact of diseases, such as COVID-19.
The drug, semaglutide, works by
hijacking the body's own appetite regulating system in the brain leading to
reduced hunger and calorie intake.
Rachel Batterham, Professor of Obesity,
Diabetes and Endocrinology who leads the Centre for Obesity Research at UCL and
the UCLH Centre for Weight Management, is one of the principal authors on the
paper which involved almost 2,000 people in 16 countries.
Professor Batterham (UCL Medicine) said:
"The findings of this study represent a major breakthrough for improving
the health of people with obesity. Three quarters (75%) of people who received
semaglutide 2.4mg lost more than 10% of their body weight and more than
one-third lost more than 20%. No other drug has come close to producing this level of
weight loss -- this really is a gamechanger.
For the first time, people can achieve through drugs what was only
possible through weight-loss surgery."
Professor Batterham added: "The
impact of obesity on health has been brought into sharp focus by COVID-19 where
obesity markedly increases the risk of dying from the virus, as well as
increasing the risk of many life-limiting serious diseases including heart
disease, type 2 diabetes, liver disease and certain types of cancers. This drug
could have major implications for UK health policy for years to come."
The average participant in the trial
lost 15.3kg (nearly 3 stone); this was accompanied by reductions in risk
factors for heart disease and diabetes, such as waist circumference, blood
fats, blood sugar and blood pressure and reported improvements in their overall
quality of life.
The trial's UK Chief Investigator,
Professor John Wilding (University of Liverpool) said: "This is a
significant advance in the treatment of obesity. Semaglutide is already
approved and used clinically at a lower dose for treatment of diabetes, so as
doctors we are already familiar with its use. For me this is particularly
exciting as I was involved in very early studies of GLP1 (when I worked at the
Hammersmith Hospital in the 1990s we were the first to show in laboratory
studies that GLP1 affected appetite), so it is good to see this translated into
an effective treatment for people with obesity."
With evidence from this trial,
semaglutide has been submitted for regulatory approval as a treatment for
obesity to the National Institute of Clinical Excellence (NICE), the European
Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
About the trial
The Phase III 'STEP'* randomised
controlled trial involved 1,961 adults who were either overweight or had
obesity (average weight 105kg/16.5 stone; body mass index 38kg/m2), and took
place at 129 sites in 16 countries across Asia, Europe, North America, and
South America.
Participants took a 2.4mg dose of
semaglutide (or matching placebo) weekly via subcutaneously (under the skin)
injection; similar to the way people with diabetes inject insulin. Overall,
94.3% of participants completed the 68-week study, which started in autumn
2018.
Those taking part also received
individual face-to-face or phone counselling sessions from registered
dietitians every four weeks to help them adhere to the reduced-calorie diet and
increased physical activity, providing guidance, behavioural strategies and
motivation. Additionally, participants received incentives such as kettle bells
or food scales to mark progress and milestones.
In those taking semaglutide, the average
weight loss was 15.3kg (nearly three stone), with a reduction in BMI of -5.54.
The placebo group observed an average weight loss of 2.6kg (0.4 stone) with a
reduction in BMI of -0.92.
Those who had taken semaglutide also saw
reductions in risk factors for heart disease and diabetes, such as waist
circumference, blood fats, blood sugar and blood pressure and reported
improvements in their overall quality of life.
About the drug
Semaglutide is clinically approved to be
used for patients with type 2 diabetes, though is typically prescribed in much
lower doses of 1mg.
The drug possesses a compound
structurally similar to (and mimics) the human glucagon-like peptide-1 (GLP-1)
hormone, which is released into the blood from the gut after meals.
GLP-1 induces weight loss by reducing
hunger, increasing feelings of fullness and thereby helping people eat less and
reduce their calorie intake.
While the STEP study has been through
Phase I and II trials, assessing the 2.4mg doses for safety, in the Phase III
trial some participants reported side effects from the drug including
mild-to-moderate nausea and diarrhoea that were transient and generally
resolved without permanent discontinuation from the study.
The international trial was funded by
the pharmaceutical company Novo Nordisk.
* Semaglutide Treatment Effect in People with Obesity (STEP)
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