It’s no secret that people have been looking for a quick and easy way to lose weight and perhaps with a so-called “magic pill”

What easier way could there be?
No change to your diet.
No need to exercise.
Just pop a magic pill!

The first GLP-1 analogue to come on the market was Exenatide, which was approved for use in type 2 diabetes in 2005. Unfortunately for pharmaceutical companies, it still isn’t clear whether these drugs actually help people with type 2 diabetes live longer, so they have remained a second-line agent, after older (and cheaper) generic drugs like Metformin and Sulfonylurea. Fortunately for pharmaceutical companies, the GLP-1 analogues were found to have one beneficial side effect that isn’t seen with either metformin or sulfonylurea… They cause people to lose weight.

Naturally, this has led to the suggestion that they could be used as weight loss drugs in people who are obese but who don’t have diabetes. Which leads us to a study that was recently published in the New England Journal of Medicine.

This was a double-blind randomized controlled trial carried out at over a hundred different sites in 16 different countries. 1,961 participants were recruited and randomized to either a GLP-1 analogue called Semaglutide or placebo. The study was funded by Novo Nordisk, which holds the patent on Semaglutide.

The Study

In order to be included in the study, participants had to be over 18 years old and they had to either have a BMI (Body Mass Index) over 30 (the cut-off for obesity), or over 27 and also have some weight related co-morbidity (e.g. high blood pressure, high cholesterol levels, sleep apnea, or heart disease). People with diabetes were excluded, since earlier studies have already shown that GLP-1 analogues are effective at reducing weight in people with type 2 diabetes. People who had previously suffered from pancreatitis (inflammation of the pancreas) were also excluded, since GLP-1 analogues have previously been shown to increase the risk of pancreatitis. The study also excluded people who had recently been taking some other form of weight loss drug, or who had had weight loss surgery.

Participants received a once-weekly injection of either Semaglutide or placebo. All participants also received traditional weight loss counselling once every four weeks, in which they were recommended to follow a low calorie/low fat diet and take regular exercise. They were followed for 68 weeks. The reason 68 weeks was chosen as the length of the study was because there was a 16 week run-in period, during which the dose of Semaglutide was gradually titrated up, followed by 52 weeks with the full dose (or a lower dose if a participant was not able to tolerate the full dose).

This is considered to be a high quality study, with lots of participants, which provides a high level of statistical power. Usually studies aim for a power of 80%, which means they have an 80% chance of finding a real difference if one exists. This study had a power of 99%! They recruited participants at lots of different sites in several different countries, which minimizes the risk that some condition specific to one setting will confound the results. The intervention received by the two groups was identical, with the one exception of getting either Semaglutide or a placebo. The participants were followed for over a year.

The average age of the participants was 46 years. The average BMI at the start of the trial was 38, and the average weight was 105 kilograms (231 pounds)

The Results!

At the end of the study, participants in the Semaglutide arm had lost 14,9% of their body weight. In the placebo arm, participants had lost 2,4% of their body weight. That means an average weight loss of 15.3 kilograms (34 pounds) in the treatment group, and 2,6 kilograms (5,7 pounds) in the placebo group. The absolute difference in weight loss between the two groups was a 12,4%. That is a big, impressive difference. On average, participants in the treatment arm lost 13 kilograms (28 pounds) more than people in the placebo arm.

Overall, 69% of participants in the Semaglutide group lost at least 10% of their body weight, compared with only 12% of participants in the placebo group. Participants in the Semaglutide group also saw a much bigger reduction in their waist circumference, losing 13,5 cm, as compared with only 4,1 cm in the placebo group.

9.8% of participants in the Semaglutide arm suffered an adverse event mainly consisting of gastrointestinal disorders, as compared with 6,4% in the placebo group. That gives an absolute difference of 3,4%, which would mean that roughly one in thirty people taking the drug for a year can expect to suffer an adverse event. There were no serious adverse events listed. In order to be classified as “serious”, an adverse event generally has to either result in death or at least be potentially life-threatening, or result in hospitalization, or result in permanent disability.

Conclusion:

In current studies, Semaglutide has proven highly effective at helping people to lose weight. Prior to the FDA approval of Semaglutude for weight loss, an earlier FDA approved drug for weight loss,  Orlistat, in one study resulted which resulted in 2-3 kilograms of weight loss over the course of a year. Semaglutide appears to blow orlistat out of the water, resulting in four to five times the amount of weight loss!

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Courtesy of VitalityHealthSFL.com - SW Florida Anti-Aging, Hormone Therapy & Weight Loss Wellness Center