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Glucagon-like peptide-1 receptor agonist
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1) (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)
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 moreSide effects data
From 2021 Phase 3 trial • 1441 Patients • NCT0401783210%
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
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
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,557 Previous Clinical Trials
2,445,643 Total Patients Enrolled
156 Trials studying Obesity
143,433 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,698 Total Patients Enrolled
11 Trials studying Obesity
18,006 Patients Enrolled for Obesity