Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
Semaglutide
Semaglutide Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.
Male or female, age greater than or equal to 18 years at the time of signinginformed consent.
Body mass index (BMI) of
greater than or equal to 28.0 kilogram per meter square (kg/m^2) or
greater than or equal to 24.0 kg/m^2 with greater than or equal to 1weight-related comorbidity (treated or untreated). Weight-related comorbiditiesshould be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea orcardiovascular disease.
- History of at least one self-reported unsuccessful dietary effort to lose bodyweight.
For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4:
Diagnosed with T2D greater than or equal to 180 days prior to screening.
Treated with either diet and exercise alone or stable treatment (same drug(s) oractive ingredient, dose and dosing frequency) for at least 60 days prior to the dayof screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone).
HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole [mmol/mol]) (both inclusive)as measured by central laboratory at screening.
Exclusion
Exclusion Criteria:
Participants without T2D at screening:
HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the centrallaboratory at screening.
History of type 1 or type 2 diabetes.
Treatment with glucose-lowering agent(s) within 90 days prior to screening.
Participants with T2D at screening:
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed by an ophthalmologist or another suitablyqualified health care provider within the past 90 days prior to screening or in theperiod between screening and randomisation. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.
Renal impairment measured as estimated glomerular filtration rate (eGFR) value oflesser than 30 milli litre per min/1.73 square metre (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.
Study Design
Connect with a study center
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Beijing Friendship Hospital, Capital Medical University-Endocrinology
Beijing, Beijing 100050
ChinaSite Not Available
Novo Nordisk Investigational Site
Beijing, Beijing 100044
ChinaSite Not Available
Peking University People's Hospital
Beijing, Beijing 100044
ChinaSite Not Available
Peking University People's Hospital-Endocrinology
Beijing, Beijing 100044
ChinaSite Not Available
Chongqing University Three Gorges Hospital
Chongqing, Chongqing 404000
ChinaSite Not Available
Novo Nordisk Investigational Site
Chongqing, Chongqing 404000
ChinaSite Not Available
Huizhou Central People's Hospital
Huizhou, Guangdong 516001
ChinaSite Not Available
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong 516001
ChinaSite Not Available
Novo Nordisk Investigational Site
Huizhou, Guangdong 516001
ChinaSite Not Available
Huaihe Hospital of Henan University
Kaifeng, Henan 475000
ChinaSite Not Available
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan 475000
ChinaSite Not Available
Novo Nordisk Investigational Site
Kaifeng, Henan 450000
ChinaSite Not Available
Novo Nordisk Investigational Site
Luo Yang, Henan 450062
ChinaSite Not Available
The First Affiliated Hospital of Henan University of science and Technology
Luo Yang, Henan 450062
ChinaSite Not Available
Novo Nordisk Investigational Site
Shiyan, Hubei 442008
ChinaSite Not Available
Taihe Hospital
Shiyan, Hubei 442008
ChinaSite Not Available
Novo Nordisk Investigational Site
Changde, Hunan 415003
ChinaSite Not Available
The First People's Hospital of Changde City
Changde, Hunan 415003
ChinaSite Not Available
The First People's Hospital of Changde City-Endocrinology
Changde, Hunan 415003
ChinaSite Not Available
Changzhou No.2 People's Hospital
Changzhou, Jiangsu 213003
ChinaSite Not Available
Novo Nordisk Investigational Site
Changzhou, Jiangsu 213003
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210011
ChinaSite Not Available
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
Jinan Central Hospital
Ji'nan, Shandong 250013
ChinaSite Not Available
Novo Nordisk Investigational Site
Jin'an, Shandong 250013
ChinaSite Not Available
Huashan Hospital Fudan University-Endocrinology
Shanghai, Shanghai 200040
ChinaSite Not Available
Novo Nordisk Investigational Site
Shanghai, Shanghai 200040
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 Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai 201200
ChinaSite Not Available
General Hospital of Tianjin Medical University
Tianjin, Tianjin 300052
ChinaSite Not Available
General Hospital of Tianjin Medical University-Endocrinology
Tianjin, Tianjin 300052
ChinaSite Not Available
Novo Nordisk Investigational Site
Tianjin, Tianjin 300052
ChinaSite Not Available
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