Effect of once-weekly subcutaneous semaglutide 2.4 mg on weight- and health-related quality of life in an East Asian population: Patient-reported outcomes from the STEP 6 trial.
Ronette L KolotkinOle Kleist JeppesenJames Baker-KnightSang Yeoup LeeAsako TokitaTakashi KadowakiPublished in: Clinical obesity (2023)
We assessed the effect of semaglutide 2.4 and 1.7 mg versus placebo on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL) in the STEP 6 trial. Adults from East Asia (body mass index [BMI] ≥27.0 kg/m 2 with ≥2 weight-related comorbidities, or ≥35.0 kg/m 2 with ≥1 weight-related comorbidity) were randomized 4:1:2:1 to once-weekly subcutaneous semaglutide 2.4 mg or placebo, or semaglutide 1.7 mg or placebo, plus lifestyle intervention for 68 weeks. WRQOL and HRQOL were assessed from baseline to Week 68 using the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) and the 36-Item-Short-Form-Survey-version-2.0 acute (SF-36v2), with changes in scores by categories of baseline BMI (</≥30 and ≥35 kg/m 2 ) also assessed. In total, 401 participants (mean body weight 87.5 kg, aged 51 years, BMI 31.9 kg/m 2 , waist circumference 103.2 cm) were included. From baseline to Week 68, the IWQOL-Lite-CT Psychosocial and Total scores were significantly improved with semaglutide 2.4 and 1.7 mg versus placebo. For Physical score, effects were only in favour of semaglutide 2.4 mg versus placebo. In the SF-36v2, Physical Functioning was significantly improved with semaglutide 2.4 mg versus placebo, but no beneficial effects favouring either semaglutide treatment arms versus placebo were seen in the other SF-36v2 domains. Benefits favouring semaglutide 2.4 mg versus placebo were also observed in subgroups with higher BMIs for IWQOL-Lite-CT and SF-36v2 Physical Functioning scores. Treatment with semaglutide 2.4 mg improved aspects of WRQOL and HRQOL in people from East Asia with overweight/obesity.
Keyphrases
- body mass index
- phase iii
- weight gain
- physical activity
- double blind
- body weight
- placebo controlled
- weight loss
- clinical trial
- open label
- phase ii
- mental health
- metabolic syndrome
- study protocol
- computed tomography
- contrast enhanced
- patient reported
- magnetic resonance
- cardiovascular disease
- liver failure
- magnetic resonance imaging
- randomized controlled trial
- drug induced
- intensive care unit
- psychometric properties
- hepatitis b virus
- dual energy
- adipose tissue
- combination therapy
- smoking cessation