Obesity
Conditions
Interventions
1. To take oral semaglutide 50 mg once daily or placebo once daily as an adjunct to reduced-calorie diet and increased physical activity
2. The trial comprises a screening period followed by a treatm
Sponsors
Hirose Ryoma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age >=18 years at the time of signing informed consent 2. Body mass index (BMI) of.>=27.0 kg/m2 with>= 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI >=35.0 kg/m2 with >=1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or T2D 3. History of at least one self-reported unsuccessful dietary effort to lose body weight For participants with T2D at screening 4. Diagnosed with T2D >= 180 days prior to screening 5. Treated with either diet and exercise alone or stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, Alpha-glucosidase inhibitor (AGI), sulphonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i)) or thiazolidinediones) 6. HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening
Exclusion criteria
Exclusion criteria: For participants without T2D 1. HbA1c >=6.5% (48 mmol/mol) as measured by the central laboratory at screening 2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records For participants with T2D at screening 3. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening For all participants 4. Treatment with any medication indicated for weight management within 90 days prior to screening 5. History of major depressive disorder within 2 years prior to screening 6. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: 1. Ralative change in body weight from baseline to end-of-treatment (%-point) 2. Achievement of body weight reduction >=5% (Yes/No) at end-of-treatment (count of subjects) | — |
Countries
Japan, South Korea
Contacts
Public ContactRyoma Hirose
Novo Nordisk Pharma Ltd.
Outcome results
None listed