ClinicalTrials.Veeva

Menu

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (OASIS 4)

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Overweight
Obesity

Treatments

Drug: Placebo semaglutide
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05564117
2021-006534-40 (EudraCT Number)
U1111-1271-9056 (Other Identifier)
NN9932-4954

Details and patient eligibility

About

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Enrollment

307 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) of
  • 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 (CV) 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

307 participants in 2 patient groups, including a placebo group

Oral semaglutide 25 mg
Experimental group
Description:
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
Treatment:
Drug: Semaglutide
Oral semaglutide placebo
Placebo Comparator group
Description:
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
Treatment:
Drug: Placebo semaglutide

Trial contacts and locations

22

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems