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Glucagon-like peptide-1 receptor agonist

Semaglutide for Obesity (OASIS 4 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 study (week 71)
Awards & highlights

OASIS 4 Trial Summary

This trial will measure how well semaglutide tablets help people lose weight over 72 weeks. Participants take either semaglutide or a placebo once daily.

Eligible Conditions
  • Obesity

OASIS 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 71)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 71) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight decreased
Relative change in body weight
Secondary outcome measures
Cognitive Therapy
Change in body mass index (BMI)
Change in diastolic blood pressure
+17 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

OASIS 4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral semaglutide 25 mgExperimental Treatment1 Intervention
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
Group II: Oral semaglutide placeboPlacebo Group1 Intervention
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,787 Total Patients Enrolled
141 Trials studying Obesity
131,757 Patients Enrolled for Obesity
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,725 Total Patients Enrolled
3 Trials studying Obesity
354 Patients Enrolled for Obesity

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05564117 — Phase 3
Obesity Research Study Groups: Oral semaglutide 25 mg, Oral semaglutide placebo
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05564117 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564117 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05564117 — Phase 3

Frequently Asked Questions

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

Did the FDA clear semaglutide for oral consumption at a standard dosage of 25 milligrams?

"Since this is a Phase 3 trial, there is available data that suggests efficacy as well as multiple rounds of safety data, making the Oral semaglutide 25 mg score a 3 on our Power scale."

Answered by AI

What is the hope for patients who participate in this trial?

"The success of this study will be judged by the participants' relative change in body weight at week 64. Additionally, number of patients who see a 10% or greater decrease in bodyweight and the amount of adverse events that occur during treatment will be monitored."

Answered by AI

Are there multiple research centers coordinating this trial?

"There are 8 different hospitals running this experiment currently. They are situated in Dallas, Birmingham, Moncton and 5 other cities. Selecting the location nearest you will limit travel time if you decide to participate in this trial."

Answered by AI

Who else is applying?

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
What state do they live in?
North Carolina
Other
Alabama
Texas
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

During the Covid lockdown I learned to cook. And I’ve been eating everything I cook! I’ve gained approximately 35lbs and I’m struggling to lose tge weight!
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
2022. "Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05564117.
~112 spots leftby Apr 2025
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