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450 Participants NeededMy employer runs this trial

Oral Semaglutide for Obesity

(OASIS 5 Trial)

Recruiting at 63 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Must not be taking: GLP-1 agonists, Amylin analogues
Disqualifiers: Recent weight change, High HbA1c, others
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity and want to lose weight. People with certain medical conditions or on specific medications may not be able to join, but the main focus is on those struggling with excess body weight.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary effort to lose body weight
Informed consent obtained before any study-related activities, including suitability determination
Body mass index (BMI) ≥ 27.0 kg/m² with at least one weight-related comorbidity such as hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease
See 3 more

Exclusion Criteria

Self-reported change in body weight greater than 5% within 90 days before screening
HbA1c ≥ 6.5% (48 mmol/mol) as measured by central laboratory at screening
I have been regularly using GLP-1 or similar diabetes medications before screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral semaglutide or placebo as an adjunct to a reduced-calorie diet and increased physical activity

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study compares different low doses of oral semaglutide (a medication taken by mouth) to a placebo (dummy pill) to see how well it helps people lose weight. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

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