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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

Summary

This trial is being conducted to see if semaglutide tablets, a new medicine, can help people living with overweight or obesity lose weight. The study will last for about 1½ year and participants will have 14 clinic visits and 7 phone calls with the study doctor.

Eligible Conditions
  • Obesity

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of body weight reduction greater than or equal to 5% (Yes/No)
Relative change in body weight
Secondary outcome measures
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
8%
Diarrhoea
7%
Upper respiratory tract infection
6%
Decreased appetite
4%
Lipase increased
4%
Vomiting
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Sitagliptin 100 mg
Oral Semaglutide 14 mg
Oral Semaglutide 7 mg

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
~6570

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,069 Total Patients Enrolled
144 Trials studying Obesity
131,819 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,488 Total Patients Enrolled
10 Trials studying Obesity
17,711 Patients Enrolled for Obesity
~174 spots leftby Jul 2025