Studie/Reference |
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STEP-1 : Wilding JP, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. NEJM 2021;384(11):989–1002. |
STEP-2 : 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;397 (10278):971–984. |
STEP-3 : 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. JAMA 2021;325(14):1403. |
STEP-4 : Rubino D, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity. JAMA 2021;325(14):1414. |
STEP-5 : NCT03693430 |
STEP-6 : Kadowaki T, et al. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diab Endo 2022;10(3):193–206. |
STEP-7 : NCT04251156 |
STEP-8 : Rubino DM, et al. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes. JAMA 2022;327(2):138. |
SELECT : NCT03574597 |
Study | Patients, criteria | Duration | Weight loss | Weight difference S2·4–P |
---|---|---|---|---|
STEP-1 | 1961 obese BMI>30/27§ | 68w | S2·4 14.9%; P 2.4% | 12.7 kg |
STEP-2 | 1210 obese & DM2 BMI>27 | 68w | S2·4 9.6%; S1·0 7.0%; P 3.4% | 6.2 kg |
STEP-3 | 611 obese BMI>30/27§ | 68w | S2·4 16.0%; P 5.7% | 10.6 kg |
STEP-4 | 902 obese BMI>30/27§ | 20 + 48w¶ | S2·4 -7.9%; P +6.9% (v20–68) | 13.2 kg |
STEP-5 | 304 obese BMI>30/27§ | 2 yrs | S2·4/P not published | |
STEP-6 | 401 obese/DM2 BMI>35/27§ | 68w | S2·4 13.2%; S1·7 9.6%; P 2.1% | ? |
STEP-7 | ~375 obese/DM2 BMI>30/27§ | 44w | S2·4/P not published | |
STEP-8 | 338 obese BMI>30/27§ | 68w | S2·4 15.8%; L3·0 6.4%; P 1.9% | 13.8 kg |
SELECT | ~17 500 CVD BMI>27 | 2½–5 yrs | S2·4/P not published |
Studies in the STEP-programme, all designed by Novo Nordisk and concerning injected semaglutide compared with placebo (in STEP-8 also liraglutide). Participants also got lifestyle counselling, typically every fourth week (more often in STEP-3). The SELECT study outcome measure is cardiovascular morbidity/mortality.
§ BMI≥30 or BMI≥27 with at least one overweight-related risk factor.
¶ Data from STEP-4 relates to change after 20 weeks treatment with semaglutide 2.4 mg followed by the same, or switch to placebo.
S2·4 semaglutide 2.4 mg weekly; L3·0 liraglutide 3.0 daily, etc; DM2 diabetes type 2, CVD cardiovascular disease.
Study | Locations§ | Completion¶ | % Women | % White | BMI mean |
---|---|---|---|---|---|
STEP-1 | Asia, EU, NA, SA | 94%/81% | 74% | 75% | 37.9 |
STEP-2 | Asia, EU, NA, SA, ME, SAfr | 96%/87% | 51% | 62% | 35.7 |
STEP-3 | USA | 93%/83% | 81% | 76% | 38.0 |
STEP-4 | USA, EU, SAfr, | 98%/92% | 79% | 84% | 38.4 |
STEP-5 | NA, EU | ||||
STEP-6 | South Korea, Japan | 99%/94% | 37% | 0% | 31.7 |
STEP-7 | China, Korea, Brazil | ||||
STEP-8 | USA | 94%/80% | 78% | 74% | 37.5 |
SELECT | Asia, EU, NA, SA, NAfr, Aust |
§ NA North America, SA South America, ME Middle East, SAfr South Africa, NAfr Northern Africa.
¶ Completion of study/completion of treatment protocol.
Mean BMI at baseline.
Study | Adverse effect profile SAE§ | Signals? |
---|---|---|
STEP-1 | SAE S2·4 9.8%; P 6.4% | gallstones |
STEP-2 | SAE S2·4 9.9%; S1·0 7.7%; P 9.2% | retinopathy |
STEP-3 | SAE S2·4 9.1%; P 2.9% | gallstones |
STEP-4 | SAE S2·4 7.7%; P 5.6% | neoplasia |
STEP-5 | ||
STEP-6 | SAE S2·4 5.0%; S1·7 7.0%; P 7.0% | retinopathy |
STEP-7 | ||
STEP-8 | SAE S2·4 7.9%; L3·0 11.0%; P 7.1% | neoplasia |
SELECT |
§ SAE serious adverse events.