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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

OASIS 1 Trial 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

OASIS 1 Trial 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
8%
Upper respiratory tract infection
4%
Diarrhoea
4%
Nausea
3%
Lipase increased
1%
Coronary artery disease
1%
COVID-19 pneumonia
1%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitagliptin 100 mg
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg
Oral Semaglutide 7 mg

OASIS 1 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
1,513 Previous Clinical Trials
2,414,362 Total Patients Enrolled
141 Trials studying Obesity
131,371 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,453 Total Patients Enrolled
10 Trials studying Obesity
17,711 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA okayed semaglutide for consumption?

"There is both clinical evidence and data from multiple rounds of testing supporting the safety of Oral semaglutide, so it received a score of 3."

Answered by AI

What are the precedents for this type of clinical trial?

"Novo Nordisk A/S sponsored the first ever clinical trial for Oral semaglutide in 2018. 1387 patients participated in the Phase 4 trial, which completed the drug approval stage that year. In the two years since, 59 more trials have been conducted in 123 cities and 55 countries."

Answered by AI

What are the most popular medical conditions that Oral semaglutide is used to manage?

"Oral semaglutide can help with managing weight in the long term, reducing the number of calories one consumes, and getting patients to be more physically active."

Answered by AI

Is Oral semaglutide a new medication?

"Currently, there are 27 Phase 3 trials and 59 total live studies concerning oral semaglutide. While some of these studies are concluding in Loma Linda, California, there are 3696 other locations conducting clinical trials for oral semaglutide."

Answered by AI

How many candidates will this research be able to accommodate?

"As of right now, this study is not looking for any more patients. The trial was created on September 13th, 2021 and was last edited on January 26th, 2022. However, if you are seeking other studies, there are 1171 trials for overweight participants and 59 trials for Oral semaglutide that are still recruiting patients."

Answered by AI

What does this clinical trial aim to achieve?

"The sponsor of this study, Novo Nordisk A/S, reports that the main objective is to achieve a body weight reduction of greater than 5%. This will be measured over a 68-week period. Additionally, this study will be assessing other outcomes, such as the number of treatment emergent adverse events, change in high sensitivity C-Reactive Protein, and change in waist circumference."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
Other
California
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

What questions have other patients asked about this trial?

What is the clinical trials.gov # so i can read up about the study?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am hoping to finally lose weight permanent with the help of this medical trial.
PatientReceived 1 prior treatment
I have tried for most of my life to lose my excess weight in a variety of ways — diets, diet pills, etc, and am hoping to find a solution that can work. I am highly motivated to see changes and have done a lot of work on myself and feel ready for a sustainable solution.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
2021. "Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05035095.
~186 spots leftby Apr 2025
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