Primary outcome
What STEP 10 measured first
| Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|
| -14.4(7.9) | -2.7(4.3) |
| Measure | Semaglutide 2.4 mgn=127 | Placebon=64 |
|---|---|---|
| Normoglycemia | 103 | 9 |
| Pre-diabetes | 23 | 53 |
| Type 2 diabetes | 1 | 2 |
Phase 3 · Semaglutide
STEP 10 trial results
Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
Change in Body Weight (Percentage [%]) (Percentage (%) of body weight), From randomisation (week 0) to end of treatment (week 52). Semaglutide 2.4 mg: -14.4; Placebo: -2.7.
- Participants
- 207
- Status
- completed
- Completed
- 2023-07-14
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT05040971), updated at source Jan 29, 2026. 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 10
Percent of participants affected, From randomisation (week 0) to week 57. The most common events the registry lists.
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Any serious event | 8.7% | 8.7% |
| COVID-19 | 34.8% | 30.4% |
| Nausea | 29% | 4.3% |
| Constipation | 18.1% | 0% |
| Diarrhoea | 12.3% | 10.1% |
| Vomiting | 11.6% | 1.4% |
| Dyspepsia | 8.7% | 4.3% |
| Decreased appetite | 8% | 1.4% |
| Headache | 4.3% | 7.2% |
| Abdominal pain upper | 5.1% | 5.8% |
| Dizziness | 5.1% | 1.4% |
| Gastrooesophageal reflux disease | 5.1% | 0% |
| Nasopharyngitis | 5.1% | 2.9% |
Secondary outcomes
What else it measured
| Semaglutide 2.4 mgn=129 | Placebon=63 |
|---|---|
| -0.4(0.3) | 0.1(0.2) |
| Semaglutide 2.4 mgn=127 | Placebon=63 |
|---|---|
| -0.8(0.6) | -0.3(0.7) |
| Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|
| -11.6(8.7) | -2.8(5.4) |
| Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|
| -9(13) | -1(13) |
| Semaglutide 2.4 mgn=126 | Placebon=62 |
|---|---|
| 0.80(36.4) | 0.96(30.6) |
| Semaglutide 2.4 mgn=127 | Placebon=63 |
|---|---|
| 0.94(16.1) | 1.01(15.7) |
| Semaglutide 2.4 mgn=119 | Placebon=61 |
|---|---|
| 1.02(12.4) | 0.99(11.7) |
| Semaglutide 2.4 mgn=118 | Placebon=61 |
|---|---|
| 0.93(26.6) | 1.03(23.6) |
| Semaglutide 2.4 mgn=125 | Placebon=62 |
|---|---|
| 0.80(36.5) | 0.96(30.7) |
| Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|
| -15.8(9.3) | -2.8(5.0) |
| Measure | Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|---|
| Yes | 111 | 17 |
| No | 18 | 49 |
| Measure | Semaglutide 2.4 mgn=129 | Placebon=66 |
|---|---|---|
| Yes | 95 | 5 |
| No | 34 | 61 |
The trial
How STEP 10 was run
This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. 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 they get is decided by chance. Participants are 2 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 skin fold in the stomach, thigh or upper arm. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
- Semaglutide: Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks
- Placebo (semaglutide): Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks
Who could join the trial
Inclusion Criteria: * Male or female aged greater than or equal to 18 years at the time of signing informed consent. * BMI greater than or equal to 30.0 kg/m\^2 * Prediabetes defined as at least one of the following: * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening. * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening. Exclusion Criteria: * History of type 1 or type 2 diabetes. * Treatment with glucose-lowering agent(s) within 90 days before screening. * HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening. * FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. * Treatment with any medication for the indication of obesity within the past 90 days before screening.
Published papers
Papers from STEP 10
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.