In the US, as well as globally, obesity is a serious problem that afflicts many. Americans love their potatoes and other starchy veggies and carbohydrates. According to the CDC, the prevalence of obesity in the US has dramatically increased from 30.5 % in the year 2000, to 42.4% in 2017-2018. Severe obesity also rose from 4.7% to 9.2%.
Often the body mass index (BMI) is used to determine whether an individual’s weight is healthy. It is calculated by dividing the weight of a person in kilos by the square of their height in meters. A BMI reading of 25 to less than 30 falls within the overweight range for adults, and 30 and more have obesity.
Any doctor will tell you obesity is a serious health concern. It reduces life expectancy, and is a major risk for cardiovascular disease, non-alcohol related fatty liver disease, some cancers (breast, ovarian, prostate, liver, colon, and endometrial cancer), and type 2 diabetes. Treatment for obesity is usually a combination of diet and exercise. Basically, a lifestyle change is essential…and if ineffective over 6 months, clinical guidelines recommend certain medications for people with a BMI of 30 and over, or those with at least a BMI of 27 if they have related health conditions. Factors to consider are costs, effectiveness and safety issues which limit the use of current medications.
Semaglutide is an injectable drug that the Food and Drug Administration (FDA) has approved for adults with type 2 diabetes and cardiovascular disease. It is an analog of the naturally occurring human glucagon-like peptide-1 (GLP-1) hormone in the body.GLP-1 is released from the gut into the bloodstream after meals, making you more satisfied, and reducing hunger and cravings. In a phase 2 clinical trial with adults with type 2 diabetes and obesity, injectable semaglutide treatment led to weight loss.
This prompted investigators to conduct a global phase 3 trial called Semaglutide Treatment Effect in People with Obesity (STEP) to test the safety and effectiveness of semaglutide in people aged 18 years and older. The group had participants with a BMI of over 27 (with health conditions) and over 30 (without health conditions). Some of the participants were given a placebo instead of the treatment. None of the participants had diabetes,used medications to treat obesity, or had undergone obesity surgery. However, the participants had some weight-related conditions – high cholesterol, hypertension, sleep apnea, or cardiovascular disease.
A total of 1,961 participants were randomly assigned to receive either the semaglutide treatment or placebo, with both groups also receiving lifestyle interventions. Over 68 weeks, 1,306 participants received the semaglutide treatment and the remaining 655 received the placebo on a weekly basis. The average body weight of the participants was 105.3 kg, the average age was 49, and the average BMI was 37.9. Also, 75% of the participants had at least one coexisting condition.
The findings
On the average, participants treated with the semaglutide significantly decreased their body weight by 14.9% (15.3 kg) as compared to those who received a placebo with 2.4% (2.6 kg.) 50% of the semaglutide group lost about 15% or more, 69% lost 10% or more, and 86% achieved a weight loss of 5% or more. The participants in the semaglutide group also had greater reductions in waist circumference, blood pressure, blood glucose, and fasting lipid levels than those in the placebo group. The trial showed reductions in risk factors for diabetes and heart disease, and a greater self-reported physical functioning in the semaglutide group.
But, there were also adverse effects. The more common would be mild to moderate nausea and diarrhea which normally subsided in time. However, more participants stopped treatment due to gastrointestinal side effects in the semaglutide group (4.5%) as compared to the placebo group (0.8%).
The limitations
Needless to say, the study had some limitations, like the exclusion of individuals with diabetes and the short duration. It was also not reflective of the general population with obesity – majority of the participants were females (74.1%), and were white (75.1%). The study was therefore not able to generalize its findings. Also, people with a phobia of needles may not wish to use an injectable drug in the long term.
One of the principal authors of the study, Rachel Batterham, M.B, B.S., Ph.D., professor of diabetes, obesity, and endocrinology at the Center for Obesity Research at University College London (UCL), and the UCL Hospitals Centre for Weight Management, had this to say:
“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.”
The pharmaceutical company funding the clinical trial, Novo Nordisk, submitted a request for regulatory approval for injectable semaglutide to treat obesity, to the FDA, the European Medicines Agency, and the National Institute for Health and Care Excellence. Still, although the trial results seem promising, it will be necessary for head-to-head trials comparing semaglutide with other standard pharmacologic and surgical treatment options to properly determine its role in treatment.
“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,“ Dr. Batterham adds. “This drug could have major implications for U.K. health policy for years to come.”
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