Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (semaglutide); Drug: Oral semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05035095

NN9932-4737

U1111-1253-1670 (Other Identifier)

2020-002953-11 (EudraCT Number)

Details and patient eligibility

About

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

• healthy food choices
• how to be more physically active
• what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

Enrollment: 667 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age greater than or equal to 18 years at the time of signing informed consent
• Body mass index (BMI):

greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m^2

• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria

• HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening
• A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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667 participants in 2 patient groups, including a placebo group

Oral semaglutide

Experimental group

Description:

Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)

Treatment:

Drug: Oral semaglutide

Oral semaglutide placebo

Placebo Comparator group

Description:

All participants are given once daily dose for 68 weeks

Treatment:

Drug: Placebo (semaglutide)