Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

Last updated: September 30, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Obesity

Treatment

Placebo (semaglutide)

Semaglutide

Clinical Study ID

NCT04251156
NN9536-4379
U1111-1212-2189
  • Ages > 18
  • All Genders

Study Summary

This study will look at the change in body weight from the start to the end of the study. The purpose of the study is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age 18 years or older at the time of signing informed consent

  • History of at least one self-reported unsuccessful dietary effort to lose bodyweight

For subjects without T2D at screening:

  • Body mass index (BMI) of :

  • greater than or equal to 30 kg/m^2

  • greater than or equal to 27 kg/m^2 with the presence of at least one of thefollowing weight-related comorbidities (treated or untreated): hypertension,dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For subjects with T2D at screening:

  • Diagnosed with T2D above or equal to 180 days prior to the day of screening

  • Treated with either:

  • diet and exercise alone or

  • stable treatment (same drug(s), dose and dosing frequency) for at least 60 daysprior to the day of screening with up to 3 oral antidiabetic medications alone or inany combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i orglitazone) according to local label

  • HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

  • BMI greater than or equal to 27 kg/m^2

Exclusion

Exclusion Criteria:

  • A self-reported change in body weight above 5 kg (11 lbs) within 90 days beforescreening irrespective of medical records

For subjects without T2D at screening:

  • HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening

For subjects with T2D at screening :

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value ofbelow 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i)according to CKDEPI creatinine equation as defined by KDIGO 2012 by the centrallaboratory 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: 375
Treatment Group(s): 2
Primary Treatment: Placebo (semaglutide)
Phase: 3
Study Start date:
December 08, 2020
Estimated Completion Date:
August 23, 2022

Connect with a study center

  • Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

    Aparecida de Goiania, Goias 74935-530
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Aparecida de Goiania, Goias 74935-530
    Brazil

    Site Not Available

  • Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

    Aparecida de Goiânia 6316406, Goiás 3462372 74935-530
    Brazil

    Site Not Available

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, Sao Paulo 01228-200
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    São Paulo, Sao Paulo 01228-200
    Brazil

    Site Not Available

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo 3448439, São Paulo 3448433 01228-200
    Brazil

    Site Not Available

  • Beijing Pinggu Hospital

    Beijing, Beijing 101200
    China

    Site Not Available

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 101200
    China

    Site Not Available

  • Beijing Pinggu Hospital-Endocrinology

    Beijing 1816670, Beijing Municipality 2038349 101200
    China

    Site Not Available

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing 1816670, Beijing Municipality 2038349 100853
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • 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

  • 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

  • Cangzhou People's Hospital

    Cangzhou, Hebei 061000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Cangzhou, Hebei 061000
    China

    Site Not Available

  • Harrison International Peace Hospital

    Hengshui, Hebei 053000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Hengshui, Hebei 053000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Cangzhou People's Hospital

    Cangzhou 1816080, Hebei 1808773 061000
    China

    Site Not Available

  • Harrison International Peace Hospital-Endocrinology

    Hengshui 1808392, Hebei 1808773 053000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University-Endocrinology

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • Inner Mongolia People's Hospital

    Huhehaote, Inner Mongolia 010020
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Huhehaote, Inner Mongolia 010020
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Huhhot, Inner Mongolia 010050
    China

    Site Not Available

  • The affiliated hospital of Inner Mongolia Medical University

    Huhhot, Inner Mongolia 010050
    China

    Site Not Available

  • Inner Mongolia People's Hospital-Endocrinology

    Hohhot 2036892, Inner Mongolia 2035607 010020
    China

    Site Not Available

  • The affiliated Hospital of Inner Mongolia Medical University-Endocrinology

    Hohhot 2036892, Inner Mongolia 2035607 010050
    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

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    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

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    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

  • Jiangsu Province Hospital-Endocrinology

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing 1799962, Jiangsu 1806260 210011
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    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

    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

  • Jinan Central Hospital

    Ji'nan, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jin'an, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jinan, Shandong 250013
    China

    Site Not Available

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan 1805753, Shandong 1796328 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Pudong New District, Shanghai 201200
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Fifth People's Hospital

    Shanghai, Shanghai 200240
    China

    Site Not Available

  • Shanghai Huashan Hospital, Affiliated to Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Tenth People's Hsopital, Tongji University

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine

    Shanghai, Shanghai 200336
    China

    Site Not Available

  • Huashan Hospital Fudan University-Endocrinology

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    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

  • Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology

    Shanghai 1796236, Shanghai Municipality 1796231 200072
    China

    Site Not Available

  • Tongren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200336
    China

    Site Not Available

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin 300211
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin 300211
    China

    Site Not Available

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin 1792947, Tianjin Municipality 1792943 300052
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin 1792947, Tianjin Municipality 1792943 300211
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Kunming, Yunnan 650101
    China

    Site Not Available

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650101
    China

    Site Not Available

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming 1804651, Yunnan 1785694 650101
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Ajou University Hospital

    Gyeonggi-do, 16499
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 16499
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Gyeonggi-do 6363696, 16499
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

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