OverweightPhase 3STEP12NCT06041217
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 21 sites in 2 countries.
Trial summary
This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 15 Sep 2023to 7 May 2025
- Phase
- Phase 3
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
- Age greater than or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m^2, with or without weight related complications at screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- For participants with T2D at screening:
- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
- Treated with either:
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- Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
- Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
- Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening.
Who cannot join
- A self-reported change in body weight greater than 5 kilograms (kg) 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.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- For participants without T2D at screening:
- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
- For participants with T2D at screening:
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
China16 sites
Beijing Hospital
Beijing, Beijing Municipality, 100730
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, 130061
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, 213003
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, 350001
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, 053000
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, 516001
Jinan Central Hospital
Jinan, Shandong, 250013
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, 210011
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 200240
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 201200
Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
Shiyan, Hubei, 442008
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001
Taiwan5 sites
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 600
China Medical University Hospital
Taichung, 404
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital_main
Taipei, 100
Taipei Medical University Hospital
Taipei, 110
About this study
Official title: Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity
This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
PlaceboDrug
Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 2.4 milligram (mg) | Experimental | Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 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 baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
Measured: At end of treatment (week 44)
Secondary outcomes (22)
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
Measured: At end of treatment (week 44)
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Body Weight (kg)
Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Body Mass Index
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Waist-height Ratio (WtHR)
Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented
Measured: Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Measured: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (%)
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (mmol/Mol)
Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mg/dL)
Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mmol/L)
Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Number of Treatment Emergent Adverse Events (TEAEs)
Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.
Measured: From baseline (week 0) to end of study (week 49)
Number of Serious Adverse Events (SAEs)
Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
Measured: From baseline (week 0) to end of study (week 49)
Change in Pulse
Change in pulse from baseline (week 0) to end of treatment (week 44) is presented.
Measured: Baseline (week 0), end of treatment (week 44)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Measured: From baseline (week 0) to end of study (week 49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Sep 2023
- Primary completion2 Apr 2025
- Study completion7 May 2025
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 OverweightStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041217
- Sponsor's protocol ID
- NN9536-4706
- Other IDs
- U1111-1273-4538
- Acronym
- STEP12
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2023
- Last updated
- 18 May 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 novonordisktrials.com
Publications
Guo L, Bao X, Huang KC, Kolnes KJ, Laugesen C, Lu Y, Luo B, Yuan G, Kushner RF. Efficacy and safety of once-weekly semaglutide 2.4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial. Lancet Diabetes Endocrinol. 2026 Aug 10:S2213-8587(26)00133-6. doi: 10.1016/S2213-8587(26)00133-6. Online ahead of print.
PubMed 42575111