OBJECTIVES

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 obesity (body mass index [BMI]≥30 kg/m²) or overweight (BMI≥27 kg/m²) plus comorbidities (STEP 1, 3 and 4), or with overweight/obesity plus type 2 diabetes (STEP 2). Semaglutide 2.4 mg was associated with weight loss versus placebo in patients receiving lifestyle interventions (STEP 1 [NCT03548935], 2 [NCT03552757] and 4 [NCT03548987]) or intensive behavioural therapy (STEP 3 [NCT03611582]). Here, we report health utility values.

METHODS

Participants completed the SF-36 Health Survey version 2 (SF-36v2) at baseline and week 68. SF-6Dv2 and estimated EQ-5D-3L utility values were derived and analysed using a mixed model for repeated measurements (without adjustment for multiplicity).

RESULTS

In STEP 1–3, mean baseline (week 0) SF-6Dv2 scores were 0.835–0.851, and EQ-5D-3L scores were 0.881–0.905. In STEP 4, baseline (week 20; after run-in semaglutide treatment for all participants) SF-6Dv2 and EQ-5D-3L scores were 0.869 and 0.926. Semaglutide was associated with small improvements by week 68 in all trials (ranges, SF-6Dv2: 0.008–0.013; EQ-5D-3L: 0.007–0.018), whereas placebo scores typically decreased (ranges, SF-6Dv2: −0.001, −0.036; EQ-5D-3L: 0.002, −0.027). SF-6Dv2 improvements versus placebo were significant (p≤0.001) in STEP 1 (0.029 [95% confidence interval: 0.012–0.046]) and STEP 4 (0.045 [0.025–0.066]), but not in STEP 2 (0.021 [−0.002–0.044], p=0.073) or STEP 3 (0.013 [−0.014–0.041], p=0.34). EQ-5D-3L improvements versus placebo were significant in STEP 1, 2 and 4 (0.029 [0.018–0.039], 0.023 [0.010–0.037], 0.034 [0.024–0.044]; all p<0.001), but not in STEP 3 (0.015 [−0.001–0.032], p=0.061).

CONCLUSIONS

In STEP 1–4, participants’ baseline utility values indicated good overall health status. Semaglutide 2.4 mg was associated with modest health utility improvements versus placebo.

DISCLOSURES

HHM and TH-H are employees of Novo Nordisk. JBB is an employee of QualityMetric Inc., LLC.