Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
placebo (semaglutide)
semaglutide 50 mg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
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 above or equal to 18 years at the time of signing informedconsent
Body mass index (BMI) of greater than or equal to 27.0 kg/m^2 with greater than orequal to 2 weight related comorbidities (treated or untreated) according to theJASSO guideline or BMI greater than or equal to 35.0 kg/m^2 with greater than orequal to1 weight related comorbidity (treated or untreated) according to the JASSOguideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2diabetes (T2D)
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), doseand dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucoseco-transporter 2 inhibitor) or thiazolidinediones)
HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratoryat screening
Exclusion
Exclusion criteria:
Participants without T2D only:
HbA1c greater than or equal to 6.5% (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
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value ofeGFR brlow 15 ml/min/1.73 m^2 according to Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation as defined by kidney disease improvingglobal outcomes (KDIGO) 2012 classification by the central laboratory at screening
Participants with T2D at screening only:
Treatment with any medication for the indication of diabetes other than stated inthe inclusion criteria within the past 60 days prior to screening
Receipt of any other anti-diabetic investigational drug within 90 days prior toscreening for this study, or receipt of any investigational drugs not affectingdiabetes within 30 days prior to screening for this study
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 eGFR value of below 30 mL/min/1.73 m^2 according to CKDEPI creatinine equation as defined by KDIGO 2012 classification by the centrallaboratory at screening
In participants treated with SGLT2i, renal impairment measured as eGFR value ofbelow 60 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined byKDIGO 2012 classification by the central laboratory at screening
The following criteria apply to all participants:
Obesity-related:
Treatment with any medication indicated for weight management within 90 days priorto screening
Previous or planned (during the study period) obesity treatment with surgery or aweight loss device. However, the following are allowed: (1) liposuction and/orabdominoplasty, if performed greater than 1 year prior to screening, (2) lapbanding, if the band has been removed greater than 1 year prior to screening, (3)intragastric balloon, if the balloon has been removed greater than 1 year prior toscreening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removedgreater than 1 year prior to screening
Uncontrolled thyroid disease per investigators discretion
A self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysbefore screening irrespective of medical records
Study Design
Connect with a study center
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Sapporo city, Hokkaido 004-0004
JapanSite Not Available
Novo Nordisk Investigational Site
Sapporo city, Hokkaido 004-0004
JapanSite Not Available
Novo Nordisk Investigational Site
Yamato-shi, Kanagawa 242-0004
JapanSite Not Available
Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa 242-0004
JapanSite Not Available
Novo Nordisk Investigational Site
Suita-shi, Osaka 565-0853
JapanSite Not Available
OCROM Clinic
Suita-shi, Osaka 565-0853
JapanSite Not Available
Naka Kinen Clinic
Ibaraki, 311-0113
JapanSite Not Available
Novo Nordisk Investigational Site
Ibaraki, 311-0113
JapanSite Not Available
Novo Nordisk Investigational Site
Minato-ku, Tokyo, 105-8470
JapanSite Not Available
Toranomon Hospital, Endocrinology and Metabolism
Minato-ku, Tokyo, 105-8470
JapanSite Not Available
Novo Nordisk Investigational Site
Osaka, 569-1045
JapanSite Not Available
Osaka University Hospital
Osaka, 565-0871
JapanSite Not Available
Takatsuki Red Cross Hospital
Osaka, 569-1045
JapanSite Not Available
Novo Nordisk Investigational Site
Sapporo City, Hokkaido, 004-0004
JapanSite Not Available
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
JapanSite Not Available
Novo Nordisk Investigational Site
Tokyo, 160-0008
JapanSite Not Available
ToCROM Clinic
Tokyo, 160-0008
JapanSite Not Available
Tokyo Center Clinic
Tokyo, 103-0028
JapanSite Not Available
Novo Nordisk Investigational Site
Yamato-shi, Kanagawa, 242-0004
JapanSite Not Available
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Daegu, 41944
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Incheon, 21565
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic ofSite Not Available
Novo Nordisk Investigational Site
Seoul, 03181
Korea, Republic ofSite Not Available
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