Obesity is a huge problem in the country since about 49.1% of the population suffers from this serious health issue. Being obese or overweight is often associated with conditions like stroke, diabetes, heart disease, and certain types of cancer. The good news is that even as little as 5% to 10% weight reduction can greatly reduce these risks – which is why many patients turn to anti-obesity medication like semaglutide to help them with chronic weight management.
So what do clinical trials have to say about the effectiveness of semaglutide for weight loss? Semaglutide injection is typically used to manage the blood sugar levels of type 2 diabetes patients, but it’s also a weight loss drug that helps patients regulate their body weight. According to the results of STEP clinical trials, patients who had subcutaneous semaglutide infusion experienced at least a 5% reduction in body weight.
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Obesity is a complex and chronic disease that puts patients at risk of different complications, but a substantial change in body weight can help them reduce their risk of developing serious health conditions. Lifestyle modification, including reduced caloric ingestion and physical activity, are important in chronic weight management, but pharmacologic interventions have also improved recently – allowing obese patients to turn to a healthier life with reduced health risks.
In June 2021, the Food and Drug Administration approved the use of Wegovy. It’s a 2.4 mg once weekly semaglutide injection developed by Novo Nordisk for managing chronic weight in obese or overweight adults with at least one weight-related condition. The weight loss medication is to be taken through an injection and administered under the skin to reduce the patient’s body weight, as well as decrease their risk of weight-associated health issues.
But like any medication, semaglutide had to undergo a clinical trial first to understand how it works and whether the benefits outweigh any adverse event that patients might experience. The Semaglutide Treatment Effect in People with Obesity (STEP) program involves the collection of 15 different Phase 3 trials that explore the semaglutide treatment effect on patients with obesity. Here’s how some of the first 4 continued semaglutide trials worked:
During the STEP 1 trial, the study covered adult patients with a body mass index (BMI) of at least 27 kg/m² with at least one obesity complication.
Some of the major exclusions of this first trial are overweight patients with diabetes mellitus and those who used other anti-obesity medications for about 12 weeks before the study. The 1961 participants were divided into semaglutide and placebo groups. The semaglutide group received dose-escalated treatments starting at a once-weekly dose of 0.25 for 4 weeks until it was slowly increased to reach a 2.4 mg dose. The entire study lasted for 75 weeks.
At the end of the STEP 1 trial, experts found that semaglutide with lifestyle intervention is more beneficial than lifestyle interventions alone. The semaglutide arm also had significant improvements in their BMI, waist circumference, blood pressure, blood sugar, and other parameters.
The second STEP trial focused on patients with a BMI of at least 27 kg/m² and HbA1c levels of about 7% to 10% (the normal rate is about 6.5% or lower). All of the participants were also diagnosed with type 2 diabetes mellitus at least 6 months before the screening. All 1210 were grouped into 3 experimental setups: those who took 2.4 mg semaglutide, 1.0 mg semaglutide, and placebo.
By the end of the STEP 2 trial, it was concluded that the type 2 diabetes mellitus patients who took semaglutide experienced more body weight reduction than those patients who only had placebo and lifestyle interventions for 68 weeks.
For the STEP 3 trial, the patients studied had the same inclusion and exclusion criteria as the first STEP trial. The 611 participants were divided into semaglutide with intensive behavior therapy or placebo with intensive behavior therapy. The addition of intensive behavior therapy is the major difference between the third STEP trial and the first two.
The participants were given low-calorie diets as meal replacements for the first 8 weeks and then changed to hypo-caloric diets of conventional food options for the rest of the trial. Physical activities were also prescribed to some patients: their goal was to have at least 100 minutes of physical activity per week.
Like the first two trials, participants in the semaglutide arm were given the anti-obesity medication in a dose-escalated manner until the target maintenance dose was reached. By the end of the trial, experts found that combining semaglutide, intensive behavior therapy, a low-calorie diet, and rigorous behavioral therapy led to meaningful improvements in the body weight of patients.
During the STEP 4 trial, the researchers also used the same patient inclusion and exclusion criteria as the STEP 1 and STEP 3 trials. All 902 participants were given semaglutide in a dose-escalated manner, but only those who were able to tolerate the highest dose of the medication were allowed to continue with the next stage of the experiment.
For the randomization period of the clinical trial, only 803 out of the initial 902 participants were left. Some of the participants were asked to take semaglutide or placebo followed by 7 weeks of no medication. They were also asked to take a 500 kcal deficit diet and 150 minutes of exercise per week that are about the same intensity as the STEP 1 trial.
In the end, the results of the STEP 4 trial showed that continuous intake of 2.4 mg subcutaneous semaglutide after a 20-week run-in period, combined with lifestyle adjustments, led to sustained body weight loss over the following 48 weeks. In contrast to this, individuals who eventually switched to placebo only regained weight.
While the previous semaglutide STEP trials studied the effects of subcutaneous semaglutide injections for chronic weight management of obese patients, another study published in December 2022 about the systematic review of randomized controlled trials (RCTs) mentioned the Pioneer trials – clinical trials that explored the effects of the oral semaglutide trial product in treating obesity.
Each Pioneer trial explored the effects of oral semaglutide under different scopes and conditions. For example, Pioneer 1 studied the safety and efficacy of various oral semaglutide doses versus placebo for patients with type 2 diabetes while Pioneer 6 explored the cardiovascular safety of oral semaglutide when reducing weight.
But like the STEP trials, the results for the Pioneer trials also showed that using semaglutide results in at least 5% body weight reduction. This is concluded by comparing the parameter to that of a placebo in patients with obesity, type 2 diabetes, or other weight-related conditions.
Aside from semaglutide, only a few obesity medications for reducing body weight, including the phentermine-topiramate combination, orlistat, liraglutide, setmelanotide, and naltrexone-bupropion combination. The European Medicines Agency (EMA) also approved the use of these medications in Europe, except for the phentermine-topiramate combination.
Including semaglutide in the list of approved medications for chronic weight management gives patients more options to help them regulate their body weight and live healthier lives. But to fully understand the effects of semaglutide and the significance of the obesity clinical trials, it’s important to learn more about the other important details of these studies:
Semaglutide is a glucagon-like peptide-1 receptor antagonist (GLP 1 RA) that’s about 94% similar to the sequence of the naturally occurring GLP 1 hormone in humans. This compound binds to the activity of the human GLP 1 receptor found in various parts of the brain that are used for appetite regulation.
Since GLP 1 is the regulator of caloric intake and appetite of humans, taking semaglutide helps an individual regulate their food intake. It also promotes weight reduction by suppressing the patient’s appetite and tricking the brain into feeling full. This makes people eat less and consume fewer calories.
Each semaglutide STEP trial followed a specific methodology, but here are some of the main categories worth considering when reading about the clinical trials:
The health and personal information of each participant is collected to ensure that they’re eligible for the criteria set by the researchers. This is to ensure that there are no external factors that might negatively affect the outcome of the STEP trials.
Since each STEP trial has a different scope, the criteria for selecting patients may also change slightly. But for most of the experiment, the basic criteria for participants is that they should be adult patients that are obese or overweight and diagnosed with at least one obesity complication.
Some STEP trials have additional criteria for patient selection, like the STEP 2 trial which had obese or overweight adults with type 2 diabetes mellitus and above-average HbA1c levels. On the other hand, STEP 4 trials required participants to tolerate the 2.4 mg semaglutide run-in period first before they were included in the randomization phase.
Another notable clinical trial is the STEP 6 trial, which had participants of East Asian heritage. They should also have to pass the additional criteria:
All demographic, medical, anthropometric, and laboratory data of participants of every STEP trial are noted before, during, and after the trials. Body weights are obtained using calibrated scales, caloric diets are recorded, observations from behavioral psychologists are noted, and other important parameters are measured every specified period.
All the collected data from the participants of every STEP trial are compared with the initial parameters, as well as the controlled trial or placebo, to see if the intake of semaglutide significantly improves the condition of obese patients. Although they have different scopes, the STEP trials showed promising results when it comes to reducing body weight and lowering the risk of weight-related and cardiovascular events.
Although STEP trials show that semaglutide causes significant improvements for chronic weight management patients, the specific results of each STEP trial should still be considered to determine how exactly the medication reacts under different conditions or when paired with other weight management methods.
According to the STEP trials, semaglutide has a good safety profile and the rate of serious side effects is similar to other GLP 1 analogs. The majority of recorded adverse effects are mostly mild gastrointestinal-related symptoms.
Based on the STEP trials 2 and 6, semaglutide seems to have a dose-response effect since higher doses resulted in more body weight reduction and fewer adverse effects. Across all STEP trials, it’s found that the rates of acute pancreatitis, hypoglycemia, injection site reactions, and gallbladder-related symptoms are low. They’re even comparable with the placebo groups.
One unexplored consequence of patients who experience more than 15% weight loss after taking semaglutide is the loss of lean muscle mass. But this adverse event is also observed in patients who took liraglutide or had bariatric surgery, suggesting that the muscle loss is related to the decreased consumption of calories.
Further testing and medical education are needed to understand the lean muscle loss mechanism and see if it’s a huge concern for obese and overweight patients.
Having a little body fat is normal, but becoming overweight or obese puts you at risk of various health problems. It also decreases your energy levels, making you feel fatigued most of the time.
If you want to start living your best life today, our weight loss experts at Dr. V Medical Aesthetics can design a medical weight loss management program for you using semaglutide treatments. Get your health back on track and know more about this procedure by booking an appointment with us today.
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