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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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
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BeijingChinaUnknown status
The First Bethune hospital of Jilin University-Endocrinology
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ChangchunChinaUnknown status
Changzhou No.2 People's Hospital, Yanghu Branch
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ChangzhouChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital-Endocrinology
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FuzhouChinaUnknown status
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
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HengshuiChinaUnknown status
Huizhou Central People's Hospital-Endocrinology
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HuizhouChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
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NanjingChinaUnknown status
Shanghai Fifth People's Hospital-Endocrinology
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ShanghaiChinaUnknown status
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
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ShanghaiChinaUnknown status
Shanghai Pudong New Area People's Hospital-Endocrinology
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ShanghaiChinaUnknown status
Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
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ShiyanChinaUnknown status
Qinghai Provincial People's Hospital
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XiningChinaUnknown status
The Affiliated Hospital of Jiangsu University-Endocrinology
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ZhenjiangChinaUnknown status
Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Chiayi CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Medical University Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital_main
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TaipeiTaiwanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.