A third (35%) of those taking a new drug to treat obesity lost more than a fifth (greater than or equal to 20%) of their total body weight, according to a large, worldwide study. to UCL researchers.

Findings from the large-scale international trial, published today in the New England Journal of Medicine, are being hailed as a “gamechanger” for improving the health of people who are obese and may close an important role in helping the UK reduce the impact of many diseases, such as COVID-19.

This drug, semaglutide, works by attacking the body’s appetite-regulating system in the brain, leading to a decrease in hunger and calorie intake.

Rachel Batterham, Professor of Obesity, Diabetes and Endocrinology, who leads the Center for Obesity Research at UCL and the UCLH Center for Weight Management, is one of the lead authors of the recent related paper. 2,000 people in 16 countries.

Professor Batterham (UCL Medicine) said: “The findings of this study represent a major breakthrough in improving the health of people with obesity. Three-quarters (75%) of those who received semaglutide 2.4mg lost more than 10% of their body weight and more than a third lost more than 20%. No other drug has achieved this weight loss – this is truly a game changer. For the first time, humans can achieve what was previously only possible through weight loss surgery using drugs.”

Professor Batterham added: “The impact of obesity on health has been highlighted by COVID-19, with obesity markedly increasing the risk of dying from the virus, as well as increasing the risk of contracting the disease. Many serious diseases shorten lives including heart disease, type 2 diabetes, liver disease and certain types of cancer. This drug could have major implications for UK health policy for years to come. “

The average test participant lost 15.3kg (almost 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 with improvements in their quality of life.

The trial’s UK lead investigator, Professor John Wilding (University of Liverpool), said: “This is a significant advance in the treatment of obesity. Semaglutide has been approved and clinically used in lower doses for the treatment of diabetes, so we physicians are familiar with its use. For me, this is particularly exciting because I was involved in very early studies of GLP1 (when I was working at Hammersmith Hospital in the 1990s, we were the first to show in studies in lab 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 to the National Institutes of Clinical Excellence (NICE), the European Medicines Agency (EMA). ) and the US Food and Drug Administration (FDA).

The trial’s UK lead investigator, Professor John Wilding (University of Liverpool), said: “This is a significant advance in the treatment of obesity. Semaglutide has been approved and clinically used in lower doses for the treatment of diabetes, so we doctors are all used to it. This is particularly exciting for me because I have been involved in very early studies of GLP1 (when I worked at Hammersmith Hospital in the 1990s, we were the first to show it in studies. lab studies that GLP1 affects appetite), so it’s good to see this translated into an effective treatment for people with obesity. “

With the evidence from this trial, semaglutide was submitted for regulatory approval as a treatment for obesity to the National Institutes of Clinical Excellence (NICE), the European Medicines Agency. (EMA) and the US Food and Drug Administration (FDA).

About testing

Phase III of the ‘STEP’ randomized controlled trial* included 1,961 overweight or obese adults (mean weight 105kg/16.5 stone; body mass index 38kg/m2), and took place at 129 locations in 16 countries across Asia, Europe, North America and South America.

Participants received a weekly dose of 2.4 mg of semaglutide (or a suitable placebo) by subcutaneous (subcutaneous) injection; similar to how people with diabetes inject insulin. Overall, 94.3% of participants completed the 68-week study, which began in the fall of 2018.

Participants also received one-on-one counseling sessions or by phone from registered dietitian nutritionists every four weeks to help them adhere to a reduced-calorie and increased physical activity diet. guidelines, action strategies and motivations. In addition, participants also receive incentives such as kettlebells or food scales to mark progress and milestones.

In those taking semaglutide, the average weight loss was about 15.3kg (roughly 3 stone), with a BMI reduction of -5.54. The placebo group observed an average weight loss of 2.6kg (0.4 ice cubes) with a BMI reduction of -0.92.

People who took semaglutide also had reduced risk factors for heart disease and diabetes, such as waist circumference, blood fats, blood sugar and blood pressure, and reported improved overall quality of life. improve.

About drugs

Semaglutide is clinically approved for use in patients with type 2 diabetes, although it is commonly prescribed in doses lower than 1mg.

The drug possesses a compound that is structurally similar to (and mimics) the human glucagon-like peptide-1 (GLP-1) hormone, which is released into the bloodstream from the intestines after a meal.

GLP-1 helps with weight loss by reducing hunger, increasing satiety and thus helping people eat less and reduce calorie intake.

While the STEP study went through Phase I and II trials, which assessed the safety of the 2.4mg dose, in the Phase III trial, some participants reported side effects from the drug including: included mild to moderate nausea and diarrhea that were short-lived and were often treated but not completely resolved in the study.

The international trial was funded by the pharmaceutical company Novo Nordisk.

*Efficacy of Semaglutide treatment in people with obesity (STEP)

Article source: Materials provided by University College London.

Link to the article: https://www.sciencedaily.com/releases/2021/02/210211091352.htm

Reference sources for journals:

1. John PH Wilding, Rachel L. Batterham, Salvatore Calanna, Melanie Davies, Luc F. Van Gaal, Ildiko Lingvay, Barbara M. McGowan, Julio Rosenstock, Marie TD Tran, Thomas A. Wadden, Sean Wharton, Koutaro Yokote, Niels Zeuthen, Robert F. Kushner. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 2021; DOI: 10.1056/NEJMoa2032183

Translator: Bao Ngan

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