Status:
COMPLETED
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and p...
Eligibility Criteria
Inclusion
- Male or female, age more than or equal to 18 years at the time of signing informed consent
- BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Exclusion
- A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT03811574
Start Date
January 21 2019
End Date
November 20 2020
Last Update
March 22 2022
Active Locations (28)
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1
Novo Nordisk Investigational Site
Adachi-ku, Tokyo, Japan, 123-0845
2
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8655
3
Novo Nordisk Investigational Site
Chitose, Hokkaido, Japan, 066-0032
4
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103-0002