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Glucagon-like peptide-1 receptor agonist

Oral semaglutide for Obesity (OASIS 1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end-of-trial (week 75)

Awards & highlights

Pivotal Trial

Summary

This trial is testing semaglutide tablets to help people with overweight or obesity lose weight. Participants will take either the new medicine or a non-active substance for over a year. Semaglutide helps reduce appetite, making it easier to eat less and lose weight. It has been shown to significantly aid in weight loss and was recently approved for long-term weight management.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end-of-trial (week 75)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end-of-trial (week 75)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end-of-trial (week 75) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of body weight reduction greater than or equal to 5% (Yes/No)

Relative change in body weight

Secondary study objectives

Achievement of body weight reduction greater than or equal to 10% (Yes/No)

Achievement of body weight reduction greater than or equal to 15% (Yes/No)

Achievement of body weight reduction greater than or equal to 20% (Yes/No)

+18 more

Side effects data

From 2021 Phase 3 trial • 1441 Patients • NCT04017832

10%

Nausea

Diarrhoea

Upper respiratory tract infection

Decreased appetite

Lipase increased

Vomiting

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 14 mg

Sitagliptin 100 mg

Oral Semaglutide 7 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral semaglutideExperimental Treatment1 Intervention

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)

Group II: Oral semaglutide placeboPlacebo Group1 Intervention

All participants are given once daily dose for 68 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral semaglutide

2021

Completed Phase 3

~7150

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