One-third (35%) of people who take a new drug to treat obesity have lost more than one-fifth (greater than or equal to 20%) of their total body weight, according to a large global study by UCL researchers were involved.
The findings of the large-scale international trial, published on February 10, 2021, in the New England Journal of Medicine, is considered a ‘game changer’ for improving the health of people with obesity and can play a major role in helping the UK to reduce the impact of diseases, such as COVID-19.
The drug, semaglutide, works by knocking down 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 heads the Center for Obesity Research at the UCL and the UCLH Center for Weight Management, is one of the lead authors on the article, which involved nearly 2,000 people in 16 countries.
Professor Batterham (UCL Medicine) said: ‘The findings of this study are an important breakthrough for improving the health of people with obesity. Three-quarters (75%) of the people who received 2.4 mg of semaglutide lost more than 10% of their body weight and more than one-third lost more than 20%. No other remedy has nearly reached the production of this weight loss – it really is a game changer. For the first time, people can achieve through drugs that were only possible through weight loss surgeries. ”
Professor Batterham added: “The impact of obesity on health has been sharply highlighted by COVID-19, where obesity significantly increases the risk of dying from the virus, as well as increasing the risk of many life-limiting serious diseases, including heart disease type. “Diabetes, liver disease and certain cancers. This drug could have major consequences for British health policy in the coming years.”
The average participant in the trial lost 15.3 kg (almost 3 stone); this was accompanied by a reduction 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 chief investigator of the trial in the UK, Professor John Wilding (University of Liverpool) said: ‘This is a major step forward in the treatment of obesity. Semaglutide has already been approved and is used clinically at a lower dose for the treatment of diabetes, so as doctors we are already familiar with its use. This is particularly exciting to me because I was very involved in GLP1 studies (when I was working at Hammersmith Hospital in the 1990s, we were the first to show in laboratory studies that GLP1 affects appetite). So it’s good to see this translated into an effective treatment for people with obesity. ”
With evidence from this trial, semaglutide was submitted for regulatory approval as a treatment for obesity at 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’ * randomized controlled trial involved 1,961 adults who were either overweight or obese (mean weight 105 kg / 16.5 stone; body mass index 38 kg / m2), and occurred at 129 sites in 16 countries across Asia, Europe, North America, and South America.
Participants took a 2.4 mg dose of semaglutide (or matching placebo) weekly under subcutaneous (under the skin) injection; similar to the way people with diabetes inject insulin. In total, 94.3% of participants completed the 68-week study, which began in the fall of 2018.
Those who participated also received individual counseling sessions every four weeks from registered dietitians to help them adhere to the diet with reduced calories and increased physical activity, with guidance, behavioral strategies, and motivation. In addition, participants received incentives such as kettlebells or food scales to mark progress and milestones.
Those taking semaglutide had an average weight loss of 15.3 kg (almost three stones), with a reduction in BMI of -5.54. The placebo group observed an average weight loss of 2.6 kg (0.4 stone) with a reduction in BMI of -0.92.
Those who took semaglutide also saw a decrease in risk factors for heart disease and diabetes, such as waist circumference, blood fats, blood sugar and blood pressure, and reported improvements in their quality of life.
About the drug
Semaglutide is clinically approved for use in patients with type 2 diabetes, but is usually prescribed in much lower doses of 1 mg.
The drug contains a compound that is structurally similar to (and mimics) the human glucagon-like peptide-1 (GLP-1) hormone, which is released into the blood after meals.
GLP-1 causes weight loss by reducing hunger, increasing feelings of fullness and thus helping people to eat less and reduce their calorie intake.
While the STEP study was conducted through Phase I and II trials, which assessed 2.4 mg doses for safety, some participants in the Phase III trial reported side effects of the drug, including mild to moderate nausea and diarrhea that were short-lived and usually resolved without permanent discontinuation of the study.
Reference: “Once a Week Semaglutide in Adults Overweight or Obese” by John PH Wilding, DM, Rachel L. Batterham, MB, BS, Ph.D., Salvatore Calanna, Ph.D., Melanie Davies, MD, Luc F Van Gaal, MD, Ph.D., Ildiko Lingvay, MD, MPH, MSCS, Barbara M. McGowan, MD, Ph.D., Julio Rosenstock, MD, Marie TD Tran, MD, Ph.D., Thomas A Wadden, Ph.D., Sean Wharton, MD, Pharm.D., Koutaro Yokote, MD, Ph.D., Niels Zeuthen, M.Sc. and Robert F. Kushner, Managing Director of the STEP 1 Study Group, February 10, 2021, New England Journal of Medicine.
DOI: 10.1056 / NEJMoa2032183
The international trial was funded by the pharmaceutical company Novo Nordisk.
* Effect of semaglutide treatment in obese people (STEP)