A report in The Lancet describes how two-thirds of patients with T2D lost at least 5% of their body weight and achieved significant blood-glucose improvement after the weekly 2.4-mg dose of the human glucagon-like peptide-1 (GLP-1) analog. In fact, according to University of Leicester–led researchers, a quarter of the study participants lost more than 15% of their body weight.
More than a quarter of patients were able to lose more than 15% of their body weight—far above that which has been observed with any other medicine administered to people with diabetes.
“These results are exciting and represent a new era in weight management in people with T2D—they mark a real paradigm shift in our ability to treat obesity, the results bring us closer to what we see with more invasive surgery,” said lead researchers Melanie Davis, MD, CBE, MB, ChB. “It is also really encouraging that along with the weight loss we saw real improvements in general health, with significant improvement in physical functioning scores, blood pressure, and blood glucose control.”
The trial, conducted at 149 outpatient clinics in 12 countries in North America, Europe, South America, the Middle East, South Africa and Asia, sought to assess the efficacy and safety of the GLP-1 analog once a week SC semaglutide 2.4 mg versus semaglutide 1.0 mg, the dose approved for diabetes treatment, and placebo for weight management in adults with overweight or obesity and T2D.
The double-blind, double-dummy, phase 3 superiority study involved more than 1,200 adults with a body-mass index of at least 27 kg/m 2 and glycated hemoglobin 7% to 10% (53–86 mmol/mol) who had been diagnosed with T2D at least 180 days before screening.
Participants were randomly allocated (1:1:1) and stratified by background glucose-lowering medication and glycated hemoglobin levels, to either SC injection of semaglutide 2.4 mg, or semaglutide 1.0 mg, or placebo that looked similar. The intervention occurred once a week for 68 weeks, plus a lifestyle intervention.
Defined as coprimary endpoints were percentage change in bodyweight and achievement of weight reduction of at least 5% at 68 weeks for semaglutide 2.4 mg versus placebo. In addition, safety was assessed in all patients who received at least one dose of study drug.
Results indicate that estimated change in mean body weight from baseline to week 68 was −9·6% (standard error, 0.4) with semaglutide 2.4 mg versus −3·4% (0.4) with placebo. Researchers report that estimated treatment difference for semaglutide 2.4 mg versus placebo was −6.2 percentage points (95% CI −7·3 to −5·2; P <.0001).
The study found that, by week 68, more patients on semaglutide 2.4 mg than on placebo had achieved weight reductions of at least 5% (267 [68.8%] of 388 vs. 107 [28.5%] of 376; odds ratio 4.88, 95% CI 3.58 to 6.64; P <.0001).
The higher dose of semaglutide was linked to more adverse events, however. Those occurred with semaglutide 2.4 mg in 353 [87.6%] of 403 patients, in 329 [81.8%] of 402) with the 1.0-mg dose and in 309 [76.9%] of 402 with the placebo. Those tended to be gastrointestinal in nature and were mostly mild to moderate.
“In adults with overweight or obesity, and T2D, semaglutide 2.4 mg once a week achieved a superior and clinically meaningful decrease in bodyweight compared with placebo,” the authors conclude.
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