A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

Last updated: January 12, 2026
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

Placebo

Semaglutide

Clinical Study ID

NCT06041217
NN9536-4706
U1111-1273-4538
  • Ages > 18
  • All Genders

Study 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. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 persquare 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 bodyweight.

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 2inhibitors (SGLT2i) or glitazone as a single agent or in combination) according tolocal label.

  • Treatment with oral anti-diabetic drugs should be stable (same drug(s) or activeingredient, 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 orequal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory atscreening.

Exclusion

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kilograms (kg) within 90 daysbefore screening irrespective of medical records.

  • Treatment with any medication for the indication of obesity within the past 90 daysbefore screening.

  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2or 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 toChronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation asdefined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification bythe central laboratory at screening.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within the past 90 days prior to screening or inthe period between screening and randomisation. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.

Study Design

Total Participants: 242
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 15, 2023
Estimated Completion Date:
May 07, 2025

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    ChongQing, Chongqing 404000
    China

    Active - Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing 1814906, Chongqing Municipality 1814905 404000
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union Hospital-Endocrinology

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union Hospital-Endocrinology

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Huizhou, Guangdong 516001
    China

    Active - Recruiting

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou 1806776, Guangdong 1809935 516001
    China

    Site Not Available

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui 1808392, Hebei 1808773 053000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shiyan, Hubei 442008
    China

    Active - Recruiting

  • Taihe Hospital

    Shiyan, Hubei 442008
    China

    Site Not Available

  • Taihe Hospital-Endocrinology

    Shiyan 1794903, Hubei 1806949 442008
    China

    Site Not Available

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu 212001
    China

    Active - Recruiting

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University_Zhenjiang

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou 1815456, Jiangsu 1806260 213003
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing 1799962, Jiangsu 1806260 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing 1799962, Jiangsu 1806260 210011
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang 1784642, Jiangsu 1806260 212001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun, Jilin 130061
    China

    Site Not Available

  • The first hospital of Jilin University

    Changchun, Jilin 130061
    China

    Site Not Available

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun 2038180, Jilin 2036500 130061
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Xining, Qinghai 810007
    China

    Active - Recruiting

  • Qinghai Provincial People's Hospital

    Xining, Qinghai 810007
    China

    Site Not Available

  • Qinghai Provincial People's Hospital

    Xining 1788852, Qinghai 1280239 810007
    China

    Site Not Available

  • Jinan Central Hospital

    Ji'nan, Shandong 250013
    China

    Site Not Available

  • Jinan Central Hospital

    Jin'an, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jin'an, Shandong 250013
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan 1805753, Shandong 1796328 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 201200
    China

    Active - Recruiting

  • Shanghai Fifth People's Hospital

    Shanghai, Shanghai 200240
    China

    Site Not Available

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai, Shanghai 200240
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine

    Shanghai, Shanghai 200336
    China

    Site Not Available

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai 1796236, Shanghai Municipality 1796231 200240
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai 1796236, Shanghai Municipality 1796231 201200
    China

    Site Not Available

  • Tongren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200336
    China

    Site Not Available

  • Harrison International Peace Hospital

    Hengshui, 053000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Hengshui, 053000
    China

    Site Not Available

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 600
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiayi City, 600
    Taiwan

    Active - Recruiting

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City 1678836, 600
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taichung, 404
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung 1668399, 404
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City, 704
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tainan City, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taipei, 100
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital_main

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taipei city, 110
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei city, 110
    Taiwan

    Site Not Available

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