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After demonstrating efficacy and safety as a weight loss agent in randomized clinical trials, a retrospective cohort study from a Mayo Clinic-led team is providing insight into the real-world effects of 2.4 mg semaglutide (Wegovy) for weight management.
With data from more than 150 patients treated at a referral center for weight management prescribed semaglutide for 3 months or more between January 1, 2021-March 15, 2022, results of the study suggest the mean weight loss achieved at 3 months was 5.9% of body weight, with this improving to 10.9% at 6 months and further analysis indicating more than 50% of semaglutide users achieving weight loss of 10% or more at 6 months.
“This study may be a stepping stone to demonstrating the effectiveness of semaglutide for patients aiming to lose weight. These results may support the applicability of semaglutide in a less controlled environment, as previously proven in RCTs,” wrote investigators.
With the US FDA’s approval of 2.4 mg semaglutide in June 2021 for chronic weight management in patients with overweight or obesity, the weekly GLP-1 receptor agonist became the first drug to receive such an approval in more than half a decade. Based on the results of the pivotal STEP program, the agent boasted a mean weight loss of 6% of body weight at 3 months and 12% of body weight at 28 weeks. Now, more than a year removed from FDA approval, investigators launched the current study citing a lack of retrospective studies assessing effectiveness of the increased doses of semaglutide outside of a clinical trial setting.
Designed as a retrospective review of electronic medical record data from individuals in the Mayo Clinic Health system using 1.7 mg or 2.4 mg semaglutide from January 1, 2021-March 15, 2022, the study’s primary endpoint of interest was the percentage of weight loss, with secondary endpoints examining the proportion of patients achieving weight loss of 5% or more, 10% or more, 15% or more, and 20% or more after 3 and 6 months as well as the percentage of weight loss for patients with or without type 2 diabetes after 3 and 6 months. For inclusion in the investigators’ analyses, individuals were required to have a BMI of 27 kg/m2 or greater and be prescribed weekly semaglutide for 3 months or more. Major exclusion criteria included hoister of bariatric procedures, receipt of other antiobesity medications, and have an active malignant neoplasm.
A total of 408 patients were identified for potential inclusion. After application of exclusion criteria and those who were denied based on insurance or a national shortage of semaglutide, 175 individuals were identified for inclusion in the investigators’ final analyses. This cohort had a mean age of 49.3 (SD, 12.5) years, 75.4% were female, and 88.0% were White. The cohort had a mean BMI of 41.3 (SD, 9.1) kg/m2, 16.0% had type 2 diabetes, and 58.3% had 6-month follow-up data available.
Upon analysis, results indicated the mean weight loss at 3 months was 6.7 (SD, 4.4) kg, which was equivalent to a mean weight loss of 5.9% (SD, 3.7%) (P <.001). At 6 months, the mean weight loss was 12.3 (SD, 6.6) kg, which was equivalent to a mean weight loss of 10.9% (SD, 5.8%) (P <.001). Among the 102 patients with at least 6 months of follow-up, 87.3% achieved a weight loss of 5% or more, 54.9% achieved a weight loss of 10% or more, 23.5% achieved a weight loss of 15% or more, and 7.8% achieved a weight loss of 20% or more. Further analysis suggested people with type 2 diabetes had. A lower mean percentage of weight loss at 3 months (3.9% [SD, 3.1%] vs 6.3% [SD, 3.7%]) and at 6 months (7.2% [SD, 6.3%] vs 11.8% [SD, 5.3%]) compared to their counterparts without type 2 diabetes (P=.005).
“The findings of this cohort study suggest that semaglutide is clinically effective for weight loss at 3 and 6 months for people with overweight or obesity,” investigators added. “Although our study lacked the stringent and closely controlled nature of RCTs, we report similar weight loss results within the same time period as in RCTs. Studies with greater sample sizes and longer periods of follow-up are further needed to support the effectiveness of semaglutide.”
This study, “Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity,” was published in JAMA Network Open.