STEP 8
Trial question
Is weekly subcutaneous semaglutide superior to daily liraglutide in adults with overweight or obesity without diabetes?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
78.0% female
22.0% male
N = 338
338 patients (265 female, 73 male).
Inclusion criteria: non-diabetic adults with a BMI of ≥ 30, or BMI of ≥ 27 plus at least one weight-related comorbidity.
Key exclusion criteria: HbA1c ≥ 48 mmol/mol; history of type 1 or T2DM mellitus; self-reported change in body weight ≥ 5 kg at 90 days of screening.
Interventions
N=126 semaglutide (initiated at 0.25 mg SC once weekly for the first 4 weeks and titrated every 4 weeks to the maintenance dose of 2.4 mg once weekly by week 16, or 1.7 mg once weekly if not tolerated, for a total of 67 weeks).
N=127 liraglutide (initiated at 0.6 mg SC daily and titrated over 4 weeks to the maintenance dose of 3 mg daily for a total of 67 weeks).
Primary outcome
Reduction in body weight
15.8%
6.4%
15.8 %
11.9 %
7.9 %
4.0 %
0.0 %
Semaglutide
Liraglutide
Significant
increase ▲
NNT = 10
Significantly greater reduction in body weight (15.8% vs. 6.4%; AD 9.4%, 95% CI 6.8 to 12).
Secondary outcomes
Significant increase in patients achieving a weight reduction of ≥ 10% (70.9% vs. 25.6%; OR 6.3, 95% CI 3.5 to 11.2).
Significant increase in patients achieving a weight reduction of ≥ 15% (55.6% vs. 12%; OR 7.9, 95% CI 4.1 to 15.4).
Significant increase in patients achieving a weight reduction of ≥ 20% (38.5% vs. 6%; OR 8.2, 95% CI 3.5 to 19.1).
Safety outcomes
No significant difference in gastrointestinal adverse events.
Conclusion
In non-diabetic adults with a BMI of ≥ 30, or BMI of ≥ 27 plus at least one weight-related comorbidity, semaglutide was superior to liraglutide with respect to reduction in body weight.
Reference
Domenica M Rubino, Frank L Greenway, Usman Khalid et al. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150.
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