Primary outcome
What STEP 6 measured first
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -9.9(7.8) | -13.4(8.6) | -1.9(5.9) |
| Measure | Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|---|
| Yes | 71 | 160 | 21 |
| No | 27 | 33 | 79 |
Phase 3 · Semaglutide
STEP 6 trial results
Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity
Change in Body Weight (%) (Percentage change), Baseline (week 0), week 68. Semaglutide 1.7 mg: -9.9; Semaglutide 2.4 mg: -13.4; Placebo: -1.9.
- Participants
- 401
- Status
- completed
- Completed
- 2020-11-20
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT03811574), updated at source Mar 22, 2022. 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 6
Percent of participants affected, Week 0 to week 75.. The most common events the registry lists.
| Event | Semaglutide 1.7 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Any serious event | 7% | 5% | 6.9% |
| Nasopharyngitis | 24% | 26.6% | 17.8% |
| Constipation | 19% | 26.1% | 3% |
| Diarrhoea | 22% | 16.1% | 5.9% |
| Nausea | 18% | 17.6% | 4% |
| Abdominal discomfort | 11% | 6% | 1% |
| Vomiting | 10% | 8.5% | 2% |
| Back pain | 8% | 9.5% | 8.9% |
| Arthralgia | 9% | 2.5% | 5.9% |
| Upper respiratory tract inflammation | 5% | 5.5% | 8.9% |
| Abdominal distension | 7% | 3.5% | 2% |
| Dizziness | 2% | 7% | 0% |
| Gastroenteritis | 7% | 5.5% | 1% |
| Decreased appetite | 5% | 6.5% | 0% |
| Abdominal pain | 3% | 6% | 0% |
| Dyspepsia | 6% | 4.5% | 1% |
| Dental caries | 4% | 5.5% | 5% |
| Abdominal pain upper | 3% | 5% | 1% |
| Headache | 2% | 5% | 3% |
Secondary outcomes
What else it measured
| Measure | Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|---|
| Yes | 41 | 117 | 5 |
| No | 57 | 76 | 95 |
| Measure | Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|---|
| Yes | 24 | 79 | 3 |
| No | 74 | 114 | 97 |
| Measure | Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|---|
| Yes | 11 | 38 | 2 |
| No | 87 | 155 | 98 |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -7.8(6.9) | -11.2(7.5) | -1.8(5.9) |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -7.6(5.7) | -10.2(6.8) | -1.9(5.3) |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -8.3(6.1) | -11.3(7.3) | -1.7(5.6) |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -3.1(2.4) | -4.3(2.8) | -0.6(2.0) |
| Semaglutide 1.7 mgn=45 | Semaglutide 2.4 mgn=86 | Placebon=43 |
|---|---|---|
| -22.3(31.3) | -41.0(23.3) | -7.1(19.5) |
| Semaglutide 1.7 mgn=45 | Semaglutide 2.4 mgn=86 | Placebon=43 |
|---|---|---|
| -41.7(47.0) | -67.4(43.0) | -13.8(38.6) |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -0.9(0.8) | -1.0(1.0) | 0.0(0.8) |
| Semaglutide 1.7 mgn=98 | Semaglutide 2.4 mgn=193 | Placebon=100 |
|---|---|---|
| -9.9(8.9) | -10.6(10.4) | -0.1(8.3) |
| Semaglutide 1.7 mgn=97 | Semaglutide 2.4 mgn=192 | Placebon=98 |
|---|---|---|
| -18.3(21.9) | -19.3(22.6) | 1.7(26.1) |
The trial
How STEP 6 was run
This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.
- Semaglutide 2.4 mg: Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.
- Placebo (semaglutide 2.4 mg): Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.
- Semaglutide 1.7 mg: Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.
- Placebo (semaglutide 1.7 mg): Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.
Who could join the trial
Inclusion Criteria: * Male or female, age more than or equal to 18 years at the time of signing informed consent * BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D) * History of at least one self-reported unsuccessful dietary effort to lose body weight * For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) Exclusion Criteria: * A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
Published papers
Papers from STEP 6
- Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. 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 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
- Kadowaki T, Nishida T, Ogawa W, Overvad M, Tobe K, Yamauchi T. Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial. Obes Res Clin Pract. 2025 Mar-Apr;19(2):146-153. doi: 10.1016/j.orcp.2025.03.003. Epub 2025 Apr 4.
- Kadowaki T, Isendahl J, Khalid U, Lee SY, Nishida T, Ogawa W, Tobe K, Yamauchi T, Lim S; STEP 6 investigators. 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 Diabetes Endocrinol. 2022 Mar;10(3):193-206. doi: 10.1016/S2213-8587(22)00008-0. Epub 2022 Feb 4.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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