Table 2 Key information of the STEP-HFpEF DM trial [61]

Dual primary endpoints

Change in KCCQ-CSS from baseline to week 52 (points)

7.3 (4.1 to 10.4)*

 < 0.001

Change in body weight from baseline to week 52 (%)

-6.4 (-7.6 to -5.2)*

 < 0.001

Confirmatory secondary endpoints

Change from baseline to week 52 in 6-min

walk distance (m)

14.3 (3.7 to 24.9)*

0.008

Hierarchical composite endpoint (crude % of wins)

1.58 (1.29 to 1.94)^§

 < 0.001

Change from baseline to week 52 in CRP level (%)

0.67 (0.55 to 0.80)^#

 < 0.001

Serious adverse events

17.7 vs 28.8

0.002

Cardiac disorders

6.1 vs 13.1

0.004

Gastrointestinal disorders

1.6 vs 1.6

1.0

Adjudicated events

Death from any cause

1.9 vs 3.3

–

CV death

0.3 vs. 1.3

–

HF event

2.3 vs. 5.9

–