. Author manuscript; available in PMC: 2024 Apr 1.

Published in final edited form as: Trends Cardiovasc Med. 2021 Dec 21;33(3):159–166. doi: 10.1016/j.tcm.2021.12.008

Table 1.

Summary of Semaglutide Treatment Effect in People with Obesity (STEP) Trials 1 to 4

Trial name	Treatment arms (N)	SBP, mm Hg	DBP, mm Hg	HbA1c, percentage points	Fasting plasma glucose, mg/dL	Total cholesterol^a	Triglycerides^a	LDL^a	HDL^a	C-reactive protein^a	Waist circumference, cm	SF-36 physical function score	SF-36 Mental health score
STEP 1	Semaglutide 2.4 mg + lifestyle intervention (1306)	−6.16^*	−2.83^*	−0.45^*	−8.35^*	0.97^*	0.78^*	0.97^*	1.05^*	0.47^*	−13.54^*	2.21^*	Favors semaglutide^*^b
	Placebo + lifestyle intervention (655)	−1.06	−0.42	−0.15	−0.48	1.00	0.93	1.01	1.01	0.85	−4.13	0.41	NR
STEP 2	Semaglutide 2.4 + lifestyle intervention (404)	−3.9^*	−1.6	−1.6^*	−2.1^*^c	0.99^*	0.78^*	1.00^*	1.07^*	0.51^*	−9.4^*	2.5^*	NS^b
	Semaglutide 1.0 + lifestyle intervention (403)^{^}	−2.9	−0.6	−1.5	−1.8^*^c	0.98	0.83^*	0.99	1.05	0.58^*	−6.7^*	2.4	NS^b
	Placebo + lifestyle intervention (403)	−0.5	−0.9	−0.4	−0.1^c	0.99	0.91	1.00	1.04	0.83	−4.5	1
STEP 3	Semaglutide 2.4 + low calorie diet for the first 8 weeks + intensive behavioral therapy (407)	−5.6^*	−3.0^*	−0.51^*	−6.73^*	−3.8^*	−22.5^*	−4.7^*	6.5	59.6^*	−14.6^*	3	−0.8^*
	Placebo + low calorie diet for the first 8 weeks + intensive behavioral therapy (204)	−1.6	−0.8	−0.27	−0.65	2.1	−6.5	2.6	5.0	−22.9%	−6.3	2.3	−2.9
STEP 4^d	Continued semaglutide 2.4 + lifestyle intervention (535)	0.5^*	0.3	−0.1^*	−0.8^*	5^*	−6^*	1^*	18	NR	−6.4^*	1.0^*	0.1^*
	Switched to placebo + lifestyle intervention (268)	4.4	0.9	0.1	6.7	11	15	8	18	NR	3.3	−1.5	−3.4

Note. SBP=systolic blood pressure. DBP=diastolic blood pressure.

p<0.05 with placebo.

^{^}

Formal statistical comparisons were not performed between semaglutide 1.0 mg and semaglutide 2.4 mg.

For STEP trials 1 and 2, values presented are a ratio of week 68 to baseline. For STEP trial 3, values presented are absolute change scores, and c-reactive protein is the percent change at week 68. For STEP trial 4, values presented are relative percent change.

Individual change scores not reported.

mmol/L.

All participants were treated with semaglutide from baseline to 20 weeks. Results presented are changes from weeks 20–68.