AIMS: Clinicians and regulatory authorities are placing increasing emphasis on health-related quality of life (HRQoL) and health utilities when evaluating therapeutic efficacy of new agents. We assessed health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) trials.

MATERIALS AND METHODS: The STEP 1-4 phase 3a, 68-week, double-blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with BMI ≥30 kg/m2 or BMI ≥27 kg/m2 and ≥1 co-morbidity (STEP 1, 3 and 4), or BMI ≥27 kg/m2 and type 2 diabetes (STEP 2). Patients received lifestyle intervention plus intensive behavioural therapy in STEP 3. HRQoL was assessed using the Short Form 36-item Health Survey version 2 (SF-36v2) at baseline and week 68. Scores were converted into Short Form Six-Dimension version 2 (SF-6Dv2) utility scores or mapped onto the European Quality of Life Five-Dimension Three-Level (EQ-5D-3L) utility index using UK health utility weights.

RESULTS: At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo typically decreased. SF-6Dv2 treatment differences by week 68 for semaglutide versus placebo were significant in STEP 1 and 4 (p≤0.001), but not STEP 2 or 3. EQ-5D-3L treatment differences by week 68 for semaglutide versus placebo were significant in STEP 1, 2 and 4 (p<0.001 for all), but not STEP 3.

CONCLUSIONS: Semaglutide 2.4 mg was associated with improvement in health utility scores compared with placebo, reaching statistical significance in STEP 1, 2 and 4. This article is protected by copyright. All rights reserved.