NCT06041217CompletedPhase 3
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- First submitted
- 11 Sept 2023
- Start date
- 15 Sept 2023
- Primary completion date
- 2 Apr 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06041217
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 242
- From 15 Sept 2023 to the primary completion date, 2 Apr 2025
- 21 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Lab values
- 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.
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune hospital of Jilin University-Endocrinology Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Changzhou No.2 People's Hospital, Yanghu Branch Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital-Endocrinology Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology Coordinator of this site? Confirm its status | Hengshui | China | Unknown status |
| Huizhou Central People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University_Nanjing Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Fifth People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Pudong New Area People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| Qinghai Provincial People's Hospital Coordinator of this site? Confirm its status | Xining | China | Unknown status |
| The Affiliated Hospital of Jiangsu University-Endocrinology Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital_main Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
Related publications
- 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 · PMID 42575111
This page is information, not medical advice. Discuss any trial with your doctor.