Phase
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Obesity
Treatment
Placebo (semaglutide)
Semaglutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiania, Goias 74935-530
BrazilSite Not Available
Novo Nordisk Investigational Site
Aparecida de Goiania, Goias 74935-530
BrazilSite Not Available
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia 6316406, Goiás 3462372 74935-530
BrazilSite Not Available
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, Sao Paulo 01228-200
BrazilSite Not Available
Novo Nordisk Investigational Site
São Paulo, Sao Paulo 01228-200
BrazilSite Not Available
CPCLIN - Centro de Pesquisas Clínicas
São Paulo 3448439, São Paulo 3448433 01228-200
BrazilSite Not Available
Beijing Pinggu Hospital
Beijing, Beijing 101200
ChinaSite Not Available
Chinese People's Liberation Army General Hospital
Beijing, Beijing 100853
ChinaSite Not Available
Novo Nordisk Investigational Site
Beijing, Beijing 101200
ChinaSite Not Available
Beijing Pinggu Hospital-Endocrinology
Beijing 1816670, Beijing Municipality 2038349 101200
ChinaSite Not Available
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing 1816670, Beijing Municipality 2038349 100853
ChinaSite Not Available
Chongqing University Three Gorges Hospital
ChongQing, Chongqing 404000
ChinaSite Not Available
Novo Nordisk Investigational Site
ChongQing, Chongqing 404000
ChinaSite Not Available
Chongqing University Three Gorges Hospital
Chongqing 1814906, Chongqing Municipality 1814905 404000
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Novo Nordisk Investigational Site
Fuzhou, Fujian 350001
ChinaSite Not Available
Fujian Medical University Union Hospital-Endocrinology
Fuzhou 1810821, Fujian 1811017 350001
ChinaSite Not Available
Cangzhou People's Hospital
Cangzhou, Hebei 061000
ChinaSite Not Available
Novo Nordisk Investigational Site
Cangzhou, Hebei 061000
ChinaSite Not Available
Harrison International Peace Hospital
Hengshui, Hebei 053000
ChinaSite Not Available
Novo Nordisk Investigational Site
Hengshui, Hebei 053000
ChinaSite Not Available
Novo Nordisk Investigational Site
Shijiazhuang, Hebei 050000
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaSite Not Available
Cangzhou People's Hospital
Cangzhou 1816080, Hebei 1808773 061000
ChinaSite Not Available
Harrison International Peace Hospital-Endocrinology
Hengshui 1808392, Hebei 1808773 053000
ChinaSite Not Available
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang 1795270, Hebei 1808773 050000
ChinaSite Not Available
Inner Mongolia People's Hospital
Huhehaote, Inner Mongolia 010020
ChinaSite Not Available
Novo Nordisk Investigational Site
Huhehaote, Inner Mongolia 010020
ChinaSite Not Available
Novo Nordisk Investigational Site
Huhhot, Inner Mongolia 010050
ChinaSite Not Available
The affiliated hospital of Inner Mongolia Medical University
Huhhot, Inner Mongolia 010050
ChinaSite Not Available
Inner Mongolia People's Hospital-Endocrinology
Hohhot 2036892, Inner Mongolia 2035607 010020
ChinaSite Not Available
The affiliated Hospital of Inner Mongolia Medical University-Endocrinology
Hohhot 2036892, Inner Mongolia 2035607 010050
ChinaSite Not Available
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu 213003
ChinaSite Not Available
Novo Nordisk Investigational Site
Changzhou, Jiangsu 213003
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu 210011
ChinaSite Not Available
Novo Nordisk Investigational Site
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University_Zhenjiang
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou 1815456, Jiangsu 1806260 213003
ChinaSite Not Available
Jiangsu Province Hospital-Endocrinology
Nanjing 1799962, Jiangsu 1806260 210029
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing 1799962, Jiangsu 1806260 210011
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260 215006
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang 1784642, Jiangsu 1806260 212001
ChinaSite Not Available
Novo Nordisk Investigational Site
Changchun, Jilin 130021
ChinaSite Not Available
The first hospital of Jilin University
Changchun, Jilin 130061
ChinaSite Not Available
The First Bethune hospital of Jilin University-Endocrinology
Changchun 2038180, Jilin 2036500 130061
ChinaSite Not Available
Jinan Central Hospital
Ji'nan, Shandong 250013
ChinaSite Not Available
Novo Nordisk Investigational Site
Jin'an, Shandong 250013
ChinaSite Not Available
Novo Nordisk Investigational Site
Jinan, Shandong 250013
ChinaSite Not Available
Jinan Central Hospital Affiliated to Shandong University
Jinan 1805753, Shandong 1796328 250013
ChinaSite Not Available
Novo Nordisk Investigational Site
Pudong New District, Shanghai 201200
ChinaSite Not Available
Novo Nordisk Investigational Site
Shanghai, Shanghai 201200
ChinaSite Not Available
Shanghai Fifth People's Hospital
Shanghai, Shanghai 200240
ChinaSite Not Available
Shanghai Huashan Hospital, Affiliated to Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai 201200
ChinaSite Not Available
Shanghai Tenth People's Hsopital, Tongji University
Shanghai, Shanghai 200072
ChinaSite Not Available
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
Shanghai, Shanghai 200336
ChinaSite Not Available
Huashan Hospital Fudan University-Endocrinology
Shanghai 1796236, Shanghai Municipality 1796231 200040
ChinaSite Not Available
Shanghai Fifth People's Hospital-Endocrinology
Shanghai 1796236, Shanghai Municipality 1796231 200240
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai 1796236, Shanghai Municipality 1796231 201200
ChinaSite Not Available
Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology
Shanghai 1796236, Shanghai Municipality 1796231 200072
ChinaSite Not Available
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai 1796236, Shanghai Municipality 1796231 200336
ChinaSite Not Available
General Hospital of Tianjin Medical University
Tianjin, Tianjin 300052
ChinaSite Not Available
Novo Nordisk Investigational Site
Tianjin, Tianjin 300211
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin 300211
ChinaSite Not Available
General Hospital of Tianjin Medical University-Endocrinology
Tianjin 1792947, Tianjin Municipality 1792943 300052
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin 1792947, Tianjin Municipality 1792943 300211
ChinaSite Not Available
Novo Nordisk Investigational Site
Kunming, Yunnan 650101
ChinaSite Not Available
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650101
ChinaSite Not Available
The Second Affiliated Hospital of Kunming Medical University
Kunming 1804651, Yunnan 1785694 650101
ChinaSite Not Available
Novo Nordisk Investigational Site
Shatin, New Territories,
Hong KongSite Not Available
Prince of Wales Hospital
Shatin, New Territories,
Hong KongSite Not Available
Ajou University Hospital
Gyeonggi-do, 16499
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Gyeonggi-do, 16499
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Suwon, 16499
Korea, Republic ofSite Not Available
Ajou University Hospital
Gyeonggi-do 6363696, 16499
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available

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