ObesityPhase 3STEP 10NCT05040971
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
A Phase 3 study testing Semaglutide 2.4 mg in people with Obesity, run by Novo Nordisk A/S at 43 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide 2.4 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 6 Sep 2021to 14 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
Canada28 sites
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, L4N 7L3
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, L6S 0C6
LMC Clin Res Inc. Calgary
Calgary, Alberta, T2H 2G4
University of Calgary
Calgary, Alberta, T2T 5C7
C-endo Diab Endo Clin Calgery
Calgary, Alberta, T2V 4J2
LMC Clin Res Inc. Thornhill
Concord, Ontario, L4K 4M2
Weight Wise Clinic
Edmonton, Alberta, T6G 2R3
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, M9R 4E1
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 2Y9
Wharton Med Clin Trials
Hamilton, Ontario, L8L 5G8
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8M 1K7
Milestone Research
London, Ontario, N5W 6A2
Manna Research Mirabel
Mirabel, Quebec, J7J 2K8
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Centre Medical Acadie
Montreal, Quebec, H4N 2W2
Clinique Medicine Urbaine du Quartier Latin, Inc.
Montreal, Quebec, QC H2L 4E9
LMC Research Inc. Ottawa
Nepean, Ontario, K2J 0V2
LMC Clinical Research Inc. Oakville
Oakville, Ontario, L6M 1M1
CHU de Quebec-Universite Laval
Québec, G1V 4G2
Institut universitaire de cardiologie
Québec, G1V 4G5
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, H4T 1Z9
Centre de recherché du CHUS
Sherbrooke, Quebec, J1H 5N4
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, J6X 4P7
Centricity Research LMC
Toronto, Ontario, M4G 3E8
Toronto Sleep Institute/MedSleep
Toronto, Ontario, M4P 1P2
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
Dr Anil K Gupta Med Prof Corp
Toronto, Ontario, M9V 4B4
United Kingdom8 sites
The Health Centre
Bradford on Avon, BA15 1DQ
University Hospital Coventry - WISDEM Centre
Coventry, CV2 2DX
Claremont Medical Practice
Exmouth, EX8 2JF
GP Direct
Harrow, HA2 0RQ
Guys Hospital
London, SE1 9RT
Clifton Medical Centre
Rotherham, South Yorkshire, S65 1DA
The Staploe Medical Centre
Soham, CB7 5JD
MyHealth - Strensall Health Care Centre
Strensall, YO32 5UA
Spain3 sites
Hospital Gregorio Marañón
Madrid, 28009
Hospital Clinico San Carlos
Madrid, 28040
Hospital Infanta Luisa
Seville, 41010
Denmark2 sites
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, 8200
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, 2650
About this study
Official title: Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Semaglutide 2.4 mg, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mgDrug
Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg
PlaceboDrug
Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks Receives: Drug: Semaglutide 2.4 mg |
| Placebo (semaglutide) | Placebo comparator | Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (Percentage [%])
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Participants With Change to Normoglycemia
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.
Measured: At week 52
Secondary outcomes (15)
Change in Glycosylated Haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Waist Circumference
Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure
Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Change in Body Weight (Kilogram [Kg])
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: At week 52
Change in Pulse
Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Measured: From randomisation (week 0) to end of treatment (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start6 Sep 2021
- Primary completion6 Jan 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040971
- Sponsor's protocol ID
- NN9536-4734
- Other IDs
- U1111-1253-1956, 2020-002939-29
- Acronym
- STEP 10
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2021
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Publications
McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietilainen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW; STEP 10 Study Group. Efficacy and safety of once-weekly semaglutide 2.4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Lancet Diabetes Endocrinol. 2024 Sep;12(9):631-642. doi: 10.1016/S2213-8587(24)00182-7. Epub 2024 Jul 29.
PubMed 39089293
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
- ClinicalTrials.gov ID
- NCT05040971
- Acronym / sponsor ID
- STEP 10 / NN9536-4734
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide 2.4 mgParticipants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks |
| Placebo (semaglutide) | Placebo comparator | Drug: PlaceboParticipants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 2.4 mgAdministered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg | Drug | Semaglutide |
| PlaceboAdministered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week | Drug | Placebo (semaglutide) |
Primary outcome
Change in Body Weight (Percentage [%])
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants With Change to Normoglycemia
Time frame: At week 52
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.
15 secondary outcomes
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Fasting Plasma Glucose (FPG)
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Waist Circumference
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: From randomisation (week 0) to end of treatment (week 52)
Change in Body Weight (Kilogram [Kg])
Time frame: From randomisation (week 0) to week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
Time frame: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
Time frame: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
Time frame: At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
Time frame: At week 52
Change in Pulse
Time frame: From randomisation (week 0) to end of treatment (week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39089293McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietilainen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW; STEP 10 Study Group. Efficacy and safety of once-weekly semaglutide 2.4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Lancet Diabetes Endocrinol. 2024 Sep;12(9):631-642. doi: 10.1016/S2213-8587(24)00182-7. Epub 2024 Jul 29.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 2.4 mg in people with Obesity, run by Novo Nordisk A/S at 43 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Canada, United Kingdom, Spain, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (Percentage [%]) (time frame: From randomisation (week 0) to end of treatment (week 52)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.