Primary outcome
What STEP 8 measured first
| Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 |
|---|---|
| -16.4(10.5) | -6.4(7.7) |
Phase 3 · Semaglutide
STEP 8 trial results
Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) (Percentage of body weight), Baseline (week 0), week 68. Semaglutide 2.4 mg: -16.4; Liraglutide 3.0 mg: -6.4.
- Participants
- 338
- Status
- completed
- Completed
- 2021-05-11
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT04074161), updated at source May 19, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in STEP 8
Percent of participants affected, From week 0 to week 75. The most common events the registry lists.
| Event | Semaglutide 2.4 mg | Liraglutide 3.0 mg | Pooled Placebo |
|---|---|---|---|
| Any serious event | 7.9% | 11% | 7.1% |
| Nausea | 61.1% | 59.1% | 22.4% |
| Constipation | 38.9% | 31.5% | 23.5% |
| Diarrhoea | 27.8% | 18.1% | 25.9% |
| Vomiting | 25.4% | 20.5% | 5.9% |
| Upper respiratory tract infection | 7.1% | 15% | 21.2% |
| Headache | 15.9% | 14.2% | 11.8% |
| Sinusitis | 6.3% | 6.3% | 15.3% |
| Eructation | 13.5% | 3.9% | 4.7% |
| Decreased appetite | 11.9% | 12.6% | 3.5% |
| Dyspepsia | 8.7% | 11.8% | 5.9% |
| Arthralgia | 6.3% | 11% | 8.2% |
| Fatigue | 9.5% | 11% | 4.7% |
| Influenza | 3.2% | 11% | 7.1% |
| Back pain | 4.8% | 7.1% | 10.6% |
| Nasopharyngitis | 7.9% | 8.7% | 10.6% |
| Gastrooesophageal reflux disease | 9.5% | 8.7% | 5.9% |
| COVID-19 | 4% | 8.7% | 5.9% |
| Abdominal distension | 5.6% | 7.1% | 8.2% |
| Dizziness | 7.9% | 5.5% | 4.7% |
| Flatulence | 7.9% | 3.1% | 7.1% |
| Abdominal pain | 6.3% | 3.9% | 1.2% |
| Hypertension | 6.3% | 2.4% | 2.4% |
| Bronchitis | 4% | 3.9% | 5.9% |
| Cough | 5.6% | 3.1% | 5.9% |
| Dry mouth | 5.6% | 4.7% | 5.9% |
Secondary outcomes
What else it measured
| Measure | Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 | Pooled Placebon=78 |
|---|---|---|---|
| Yes | 83 | 30 | 12 |
| No | 34 | 87 | 66 |
| Measure | Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 | Pooled Placebon=78 |
|---|---|---|---|
| Yes | 65 | 14 | 5 |
| No | 52 | 103 | 73 |
| Measure | Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 | Pooled Placebon=78 |
|---|---|---|---|
| Yes | 45 | 7 | 2 |
| No | 72 | 110 | 76 |
| Semaglutide 2.4 mgn=114 | Liraglutide 3.0 mgn=113 | Pooled Placebon=76 |
|---|---|---|
| -13.6(10.0) | -6.8(8.4) | -2.0(7.2) |
| Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 | Pooled Placebon=78 |
|---|---|---|
| -15.8(10.2) | -6.8(9.5) | -1.4(9.6) |
| Semaglutide 2.4 mgn=117 | Liraglutide 3.0 mgn=117 | Pooled Placebon=78 |
|---|---|---|
| -16.4(10.5) | -6.4(7.7) | -1.6(8.6) |
| Semaglutide 2.4 mgn=114 | Liraglutide 3.0 mgn=112 | Pooled Placebon=77 |
|---|---|---|
| -7(14) | -4(15) | 5(14) |
| Semaglutide 2.4 mgn=114 | Liraglutide 3.0 mgn=112 | Pooled Placebon=77 |
|---|---|---|
| -5(9) | -1(11) | 1(9) |
| Semaglutide 2.4 mgn=112 | Liraglutide 3.0 mgn=106 | Pooled Placebon=74 |
|---|---|---|
| 0.92(12.9) | 1.00(15.0) | 0.99(17.6) |
| Semaglutide 2.4 mgn=112 | Liraglutide 3.0 mgn=106 | Pooled Placebon=76 |
|---|---|---|
| 0.92(12.9) | 1.00(15.0) | 0.99(17.6) |
| Semaglutide 2.4 mgn=111 | Liraglutide 3.0 mgn=106 | Pooled Placebon=73 |
|---|---|---|
| 0.99(14.7) | 1.02(14.4) | 0.99(15.4) |
| Semaglutide 2.4 mgn=111 | Liraglutide 3.0 mgn=106 | Pooled Placebon=73 |
|---|---|---|
| 0.99(14.7) | 1.02(14.4) | 0.99(15.4) |
The trial
How STEP 8 was run
This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Semaglutide: Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
- Placebo (semaglutide): Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
- Liraglutide: Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
- Placebo (liraglutide): Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Who could join the trial
Inclusion Criteria: * Male or female, age 18 years or older at the time of signing informed consent * Body mass index (BMI) equal to or above 30.0 kg/m\^2 or equal to or above 27.0 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus * A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Published papers
Papers from STEP 8
- Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.
- Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. 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. doi: 10.1001/jama.2021.23619.
- Snitker S, Egebjerg C, Frederiksen M, Sparre T. Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Diabetes Obes Metab. 2022 Nov;24(11):2273-2276. doi: 10.1111/dom.14809. Epub 2022 Aug 7. No abstract available.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.