For decades, people have fought an uphill battle when it comes to weight-loss management. According to the Centers for Disease Control and Prevention, since 1960, adult obesity in the United States has nearly tripled from 13% from 1960 through 1962 to 36% from 2009 through 2010. Often, lifestyle intervention is insufficient in treating obesity; however, when combined with medication, weight loss and the reduction of complications associated with weight loss can be achieved. Two common types of medications that can assist with this endeavor include semaglutide and metformin.
What Is Semaglutide?
An antidiabetic medication, semaglutide is a drug used for the treatment of type 2 diabetes and received approval from the FDA in early 2021 for long-term weight management as an adjunct to exercise and diet. You might find the injected form of semaglutide listed under the brand names Ozempic and Wegovy while the tablet form under the brand name Rybelsus, all of which are manufactured by Novo Nordisk.
This medication is the first drug treatment to be FDA-approved for weight management since 2014. It's part of a group of medications called glucagon-like peptide-1 (GLP-1) receptor agonists that balances out hormones such as insulin, which helps to regulate blood sugar. As a result, it potentially curbs appetites and allows you to lose weight because you eat less.
When a doctor prescribes semaglutide, you either take it as a metered injection or in oral form. One of its main advantages is that it has a long duration, so in most cases a once-a-week injection suffices. Early studies showed that the medication produced moderate weight loss at its weekly 1 mg dosage. Patients with a body mass index (BMI) of 30 or more or 27 with related conditions such as diabetes are typically prescribed weekly 2.4 mg injections.
Research has shown that at higher doses, semaglutide could also prevent and treat diabetes, cardiovascular disease, and other related issues such as sleep apnea and osteoarthritis. The reasoning behind this is that patients are not only losing weight but also improving their health. It's important to note that semaglutide's side effects are mild, and you might experience temporary symptoms such as diarrhea, nausea, vomiting, and constipation. These are very management symptoms and tend to occur during the beginning of the course of treatment.
What Do Studies Show About Semaglutide?
In 2020 and 2021, Novo Nordisk announced the results of five phase-three trials involving the Semaglutide Treatment Effect in People (STEP). These results, which were published in the New England Journal of Medicine, involved researchers at Northwestern University and were conducted to determine the efficacy and safety of the larger 2.4 mg dosage on weight loss.
STEP was one of the largest clinical trial programs for obesity management. Approximately 5,000 people participated in the study, and they had a mean age of 46.2 to 55.3 years and were mostly female. They also had a mean BMI of 35.7 to 38.5, with all of them having a BMI of at least 30 or 27 with a pre-existing condition related to their weight that wasn't type 2 diabetes. These participants also had a history of at least one unsuccessful dietary effort to lose weight.
- STEP 1: This trial had 1,961 obese or overweight adults who didn't suffer from type 2 diabetes received either the 2.4 mg dosage or placebo to assess their weight loss. A portion of that group had their body composition assessed by dual-energy X-ray absorptiometry to determine if weight loss is caused by a reduction in fat loss prompted by the treatment.
- STEP 2: With this trial, 1,210 obese or overweight adults who have type 2 diabetes received the 2.4 mg dosage, the 1.1 dosage, or the placebo. The results were compared to determine weight loss results.
- STEP 3: In this trial, 611 overweight or obese adults who did not have type 2 diabetes received either the 2.4 dosage or the placebo. The treatment options for this group followed those found with intensive behavioral therapy programs. They also followed an intensive eight-week low-calorie diet followed by 60 weeks of increased physical activity and a hypocaloric diet.
- STEP 4: For this trial, 902 overweight or obese adults who did not have type 2 diabetes received 2.4 mg of semaglutide a week. Approximately 750 of those 902 participants who completed the 20-week introductory period were randomly assigned to either continue to receive the same dosage or a placebo for an extra 48 weeks. Also, this group had withdrawal assistance to assess any change in weight due to switching from the semaglutide to a placebo.
- STEP 5: This long-term trial had 304 overweight or obese participants who did not have type 2 diabetes and either received the 2.4 mg dosage of semaglutide or a placebo. They participated in this trial for two years to assess weight loss.
In addition to either the semaglutide or placebo, participants received lifestyle intervention except for those who were part of the STEP 3 group. Those who had the lifestyle intervention had a reduction of 500 calories per day as well as received a recommended 150 minutes a week of exercise.
The results from the group are as followed:
- STEP 1: The mean change in body weight for those taking the semaglutide from the baseline was 14.9% over 68 weeks compared to a 2.4% decrease for those taking the placebo.
- STEP 2: This 68-week randomized trial saw a 9.6% reduction in body weight for those taking the 2.4 mg dosage, while those who took the 1.0 mg dosage saw a 7.0% reduction. Participants who were assigned the placebo had a 3.4% reduction in body weight.
- STEP 3: For this 68-week trial, those who took the 2.4 mg dosage and the IBT treatment plan saw a weight loss of 17.6% compared to a 5.0% reduction in weight loss for those who had the placebo plus IBT.
- STEP 4: During the 20-week trial, participants who took the 2.4 mg dosage had a 10.6% reduction in body weight. Those who continued on with the additional 48 weeks and the 2.4 mg dosage saw a 7.9% reduction in body weight. However, those who switched to the placebo at 20 weeks gradually regained their weight and saw a 6.9% increase in body weight.
- STEP 5: This trial, which culminated in November 2021, showed that participants who received the 2.4 mg injection achieved significant and sustained weight loss over the two-year period. Those who took the semaglutide achieved a 15.2% loss in body weight compared to the 2.6% loss for those on the placebo.
Results from the trials show that semaglutide is effective in weight-loss management in individuals who have type 2 diabetes and those who do not. Overall, participants who were on semaglutide lost on-average nearly 15% of their body weight, while those in the placebo group lost an average of 2.4%. In a number of patients, their diabetes and pre-diabetes symptoms improved. As a result of the trial, the Food and Drug Administration granted approval for the treatment in June 2021.
If you have more questions about the benefits of semaglutide or other weight-loss options, reach out to the medical professionals at the biostation. Our personalized approach to wellness begins with advanced diagnostic testing, with our goal to help you heal and restore your body to its peak performance. Contact us today for a virtual consultation to get you started on your weight-loss journey.