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Efficacy and safety of oral semaglutide 50 mg once daily in subjects with overweight or obesity (OASIS 1)

Efficacy and safety of oral semaglutide 50 mg once daily in subjects with overweight or obesity (OASIS 1)

Nishida Hiroko

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

JPHC_clinical_trials@novonordisk.com

Nishida Hiroko

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

JPHC_clinical_trials@novonordisk.com

Complete

Sept. 13, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male or female, age >= 18 years at the time of signing informed consent
2. Body mass index (BMI):
a) >=27.0 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
b)>= 30.0 kg/m2
3. History of at least one self-reported unsuccessful dietary effort to lose body weight

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

Both

Obesity

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 treatment period and a follow up period. The treatment period is divided into a dose escalation period of 16 weeks and a maintenance period of 52 weeks
3. To perform assessments specified in the protocol

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)

+81-3-6779-8166

Aug. 04, 2021

No

Canada/Denmark/Finland/France/Germany/United States/Poland/Russia