Semaglutide is Changing the Course of Weight Loss. Here is the Research.
Semaglutide injected once weekly, along with healthy diet and lifestyle changes has shown to help people dealing with obesity lose a significant amount of weigh. The recent study conducted by Novo Nordisk, known as the Semaglutide Treatment Effect in People with Obesity (STEP) 1 studyopens in a new tab or window found.
This study which began in the Fall of 2019 and eneded in 2020 was a double-blind trial of 1,961 adults with a body mass index (BMI) of 30 or higher, adults on the program who took a weeklyinjection of semaglutide lost an average 14.9% of baseline body weight after 68 weeks of treatment versus only 2.4% for the placebo group which had lifestyle intervention alone (treatment difference -12.4%, 95% CI -13.4 to -11.5, P<0.001). Robert Kushner, MD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.
A total of 86.4% of adults on semaglutide were able to cut at least 5% of their baseline body weight during the trial compared with only 31.5% of those adhering to lifestyle intervention alone, the researchers wrote in the study online in the New England Journal of Medicineopens in a new tab or window. Beyond that, almost 70% of those on semaglutide with lifestyle intervention achieved a 10% or more weight loss, and more than half were able to lose 15% of their baseline body weight.
In total, adults on semaglutide treatment lost an average 33.7 lb (15.3 kg) by week 68, while those in the placebo/lifestyle intervention group saw only a modest 5.7 lb (2.6 kg) weight loss (estimated treatment difference -30 lb [-12.7 kg], 95% CI -13.7 to -11.7). These differences are surely statistically significant.
Other Semaglutide Benefits Beyond Weight Loss
In addition to weight loss, semaglutide also improved cardiovascular risk factors including greater reductions in waist circumference, BMI, systolic and diastolic blood pressures, HbA1c, fasting plasma glucose, C-reactive protein, and fasting lipid levels, as well as physical functioning scores and quality of life.
What Medical Experts are Saying about Semaglutide
“I was surprised and gratified to see the unprecedented results from the medication,” Kushner told MedPage Today. “The fact that 50% of participants were able to lose at least 15% of initial body weight and one-third lost at least 20% body weight is a game changer.”
“Semaglutide is by far the most effective drug intervention we have seen for weight management,” he continued. “We know that a lot of the health concerns we see in people who struggle with their weight, such as type 2 diabetes, hypertension, GERD [gastroesophageal reflux disease], and arthritis of the weight-bearing joints, are improved by losing at least 10% of their body weight. In this study, nearly 70% of participants were able to achieve this 10% weight loss threshold by taking semaglutide.”
As for the next steps, Kushner said it’s all about putting this into practice: “We now need to explore how to encourage and educate healthcare providers to provide obesity care in the primary care setting.”
The STEP 1 trial included 1,961 adults with a BMI of 30 or greater, or those with a BMI of 27 or greater with at least one weight-related comorbidity, randomized in a 2:1 fashion. All participants were free of diabetes at baseline — although 40% had prediabetes — and about 75% of the cohort were female and white.
Those who received semaglutide were started on a dose of 0.25 mg once weekly for the initial 4 weeks, which was subsequently titrated up every 4 weeks until the maintenance dose of 2.4 mg was achieved by week 16.
Both study groups received individual diet-related counseling sessions every 4 weeks aimed at encouraging a 500-kcal deficit per day paired with a goal of 150 minutes of physical activity per week.
Adverse events were similar to what has already been demonstrated with semaglutide, with gastrointestinal side effects being the most common, the team said.
Overall, about 74% of those on semaglutide reported at least one gastrointestinal side effect — mostly nausea, diarrhea, vomiting, or constipation — versus 48% of those on placebo. About 4.5% of those on semaglutide ended up discontinuing treatment due to gastrointestinal events vs 0.8% of those on placebo.
Based on the results of the phase III STEP program, Novo Nordisk is now seeking U.S. marketing approval foropens in a new tab or window semaglutide for chronic weight management.
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