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
- 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
- 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:
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06041217
- Acronym / sponsor ID
- STEP12 / NN9536-4706
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Posted 18 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 2.4 milligram (mg) | Experimental | Drug: SemaglutideParticipants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
- 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.
Key exclusion criteria (8 listed)
- 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.
- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
- 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.
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 |
|---|---|---|
| SemaglutideSubcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached. | Drug | Semaglutide 2.4 milligram (mg) |
| PlaceboSubcutaneous 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. | Drug | Placebo |
Primary outcome
Change in Body Weight (%)
Time frame: Baseline (week 0), end of treatment (week 44)
Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Time frame: At end of treatment (week 44)
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.
22 secondary outcomes
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Time frame: At end of treatment (week 44)
Change in Waist Circumference
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Body Weight (kg)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Body Mass Index
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Waist-height Ratio (WtHR)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Systolic Blood Pressure
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Diastolic Blood Pressure
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (%)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (mmol/Mol)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mg/dL)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mmol/L)
Time frame: Baseline (week 0), end of treatment (week 44)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to end of study (week 49)
Number of Serious Adverse Events (SAEs)
Time frame: From baseline (week 0) to end of study (week 49)
Change in Pulse
Time frame: 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)
Time frame: From baseline (week 0) to end of study (week 49)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42575111Guo 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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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. 2834) study director
Novo Nordisk A/S
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 21 sites in 2 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 9 inclusion and 8 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China, Taiwan. 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 18 May 2026). 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 (%) (time frame: Baseline (week 0), end of treatment (week 44)). 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 NCT06041217, 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 18 May 2026.