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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 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 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
8%
Diarrhoea
7%
Upper respiratory tract infection
6%
Decreased appetite
4%
Vomiting
4%
Lipase increased
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg
Sitagliptin 100 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
~6770

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,403 Total Patients Enrolled
151 Trials studying Obesity
142,695 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
~167 spots leftby Sep 2025
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