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Semaglutide plus intensive behavioral therapy was found to be associated with substantial, sustained, and clinically relevant mean weight loss compared with placebo in overweight or obese adults without type 2 diabetes, according to research presented at the 30th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (ENVISION 2021).
In a post hoc subgroup analysis of the STEP 3 trial (ClinicalTrials.gov Identifier: NCT03611582), investigators sought to determine whether participants’ baseline characteristics and weight history would affect weight loss with semaglutide, a glucagon-like peptide-1 receptor agonist, compared with placebo plus intensive behavioral therapy. Adults without type 2 diabetes and with obesity or who were overweight and had 1 or more weight-related comorbidity were randomly assigned 2:1 to intensive behavioral therapy plus either once-weekly semaglutide 2.4 mg administered subcutaneously or placebo for 68 weeks. Weight loss distribution was assessed in 498 participants who were on treatment and had a body weight measurement at week 68; 334 participants were in the semaglutide group and 164 were in the placebo group.
The study authors analyzed mean weight loss percentage according to subgroups of baseline characteristics and weight history with use of a mixed model for repeated measurements in the overall cohort from STEP 3. Participants were categorized according to baseline age, sex, race, ethnicity, body weight, body mass index (BMI), and weight history obtained from a self-report questionnaire.
Participants’ overall mean age was 46 years (81% women), with a mean body weight of 105.8 kg and a mean BMI of 38.0 kg/m2.
The researchers found greater proportions of patients treated with semaglutide in the higher weight loss categories compared with those who received placebo. Participants with at least a 20% weight loss included 38.6% of the semaglutide group compared with 4.3% of the placebo group. Participants who had 15% to less than 20% weight loss included 21% of the semaglutide group and 8.5% of the placebo group.
At week 68, the mean percentage of weight loss was significantly greater in patients who used semaglutide compared with placebo regarding all baseline clinical characteristic subgroups including age, sex, race, ethnicity, body weight, and BMI (P <.01 for treatment differences).
The mean percentage of weight loss was significantly greater among those who received semaglutide vs placebo in all subgroups defined by weight history: age of onset, maximum pretrial-to-trial baseline weight, weight cycling, and family history (P <.01 for treatment differences). Similar treatment effects were found among the weight-history subgroups, with semaglutide treatment leading with 15.2% to 18.8% weight loss at week 68 compared with 2.7% to 7.6% with placebo.
No significant subgroup interactions were observed for any parameter other than BMI (interaction P =.01 for BMI, P >.05 for all other parameters).
“Clinical baseline characteristics and weight history had minimal effects on weight loss with semaglutide, suggesting potential benefits of this treatment for a wide range of people with overweight or obesity,” the investigators concluded.
Disclosures: The trial was sponsored by Novo Nordisk. One of the authors of the abstract of the poster is affiliated with Novo Nordisk A/S. Please see the original reference for a full list of disclosures.
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Garvey WT, Hesse D, Holst-Hansen T, et al. Once-weekly subcutaneous semaglutide 2.4 mg plus intensive behavioral therapy produces clinically meaningful weight loss in adults with overweight/obesity regardless of baseline characteristics and weight history. Presented at: 2021 AACE Virtual Annual Meeting, May 26-29, 2021.