HealthRX.com · Printable question sheet
STEP trial reading sheet: which result fits your situation
Match a STEP trial result to your own situation before relying on it: who the trial enrolled, what the comparison arm received, how long it ran and what the number measures. Questions for your prescriber are at the end.
What each trial tested
- STEP 1: 1,961 adults without diabetes, BMI 30 or more (27 or more with a weight-related condition), 68 weeks, semaglutide 2.4 mg against placebo.[1]
- STEP 2: 1,210 adults with type 2 diabetes and BMI 27 or more, 68 weeks, semaglutide 2.4 mg, semaglutide 1.0 mg or placebo.[2]
- STEP 3: 611 adults without diabetes, 68 weeks; both arms had a low-calorie diet for the first 8 weeks and 30 counseling visits.[3]
- STEP 5: 304 adults without diabetes, 152 per arm, followed to week 104.[4]
- STEP 8: 338 adults without diabetes in all, 68 weeks; semaglutide 2.4 mg compared open-label with daily liraglutide 3.0 mg (127 on liraglutide), and 85 of the 338 on pooled placebo.[5]
Your situation
Type 2 diabetesyes or no
BMI and any weight-related conditions
Lifestyle support you will havebrief counseling, or an intensive program with many visits
GLP-1 medicines used beforefor example liraglutide
How long you expect to stay on treatment
Before quoting a STEP number
- Which trial, and which arm, the number belongs to
- Whether it is change from baseline or the difference from the comparator
- What the comparator received: placebo, an intensive program, or another drug
- The week it was measured
- Whether it counts everyone randomized or only people who stayed on treatment
For your prescriber
- Which STEP trial enrolled people most like me?
- If I have type 2 diabetes, which trial's results apply to me?
- Will I have a structured lifestyle program, and how does it compare with what STEP 3 provided?
- What tends to happen to weight if treatment stops, and which trial studied that?
- How long do you expect me to stay on treatment, and how will we judge whether it is working?
Sources for the facts on this sheet
- Wilding JPH, et al.. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med 2021. PMID 33567185. https://pubmed.ncbi.nlm.nih.gov/33567185/
- Davies M, et al.. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet 2021. PMID 33667417. https://pubmed.ncbi.nlm.nih.gov/33667417/
- Wadden TA, et al.. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA 2021. PMID 33625476. https://pubmed.ncbi.nlm.nih.gov/33625476/
- Garvey WT, et al.. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med 2022. PMID 36216945. https://pubmed.ncbi.nlm.nih.gov/36216945/
- Rubino DM, 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. PMID 35015037. https://pubmed.ncbi.nlm.nih.gov/35015037/
This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.