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GLP-1 Receptor Agonist

Semaglutide for Obesity

Jacksonville, FL
Phase 4
Recruiting
Led By Andres Acosta, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of bariatric surgery including lap band and bariatric endoscopy
Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial is testing if a saliva test can predict how well semaglutide works for treating obesity."

See full description
Who is the study for?
This trial is for adults with obesity (BMI ≥30 kg/m2), possibly with controlled chronic conditions like hypertension. It's not for those who've had significant weight changes recently, are pregnant or planning to be, have a history of bariatric surgery, untreated severe psychiatric issues, substance or eating disorders, suicidal behavior, alcohol abuse problems, or are using anti-obesity drugs.Check my eligibility
What is being tested?
The study tests if saliva biomarkers can predict how well someone with obesity will respond to Semaglutide—a medication used for weight loss. Participants will either receive Semaglutide or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Semaglutide may cause side effects such as nausea, vomiting, diarrhea, constipation and abdominal pain. Some people might also experience changes in appetite or heartburn.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had weight loss surgery in the past.
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I am currently taking medication for weight loss or Type 2 Diabetes.
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I cannot take certain FDA-approved diabetes medications.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Total Body Weight at 24 weeks
Secondary study objectives
Change in Total Body Weight at 3 months
Change in Total Body Weight at 6 months
Change in Waist Circumference
+4 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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: Semaglutide GroupExperimental Treatment1 Intervention
Subjects will take semaglutide weekly for 24 weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will take placebo weekly for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Closest Location:Mayo Clinic in Rochester· Rochester, MN· 562 miles

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,413 Previous Clinical Trials
3,208,688 Total Patients Enrolled
91 Trials studying Obesity
9,541 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,891 Previous Clinical Trials
8,050,625 Total Patients Enrolled
109 Trials studying Obesity
26,970 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,501 Previous Clinical Trials
4,353,972 Total Patients Enrolled
478 Trials studying Obesity
583,900 Patients Enrolled for Obesity
Phenomix SciencesUNKNOWN
Andres Acosta, MD, PhDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
130 Total Patients Enrolled
2 Trials studying Obesity
115 Patients Enrolled for Obesity
~90 spots leftby Dec 2027
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