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Liraglutide + Sleeve Gastrectomy for Obesity
Phase 3
Waitlist Available
Led By Adrian Vella
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights
Study Summary
This trial will study whether the weight-loss drug liraglutide, added to sleeve gastrectomy, leads to greater weight loss than surgery alone.
Who is the study for?
This trial is for adults aged 20-65 planning to undergo Sleeve Gastrectomy at Mayo Clinic, without physical illnesses affecting mobility or weight loss. Women must use birth control if taking part. Excluded are those with recent glucose-lowering meds use, diabetes indicators, certain past surgeries, pregnancy plans during the study, liraglutide sensitivity, family history of specific cancers, insulin/GLP-1 agonist use, severe psychiatric conditions or a history of pancreatitis and gallbladder issues.Check my eligibility
What is being tested?
The study tests whether adding Liraglutide (a GLP-1 receptor agonist) after Sleeve Gastrectomy surgery aids in weight loss and improves cardiovascular risk factors compared to a placebo. Participants will be randomly assigned to receive either Saxenda (Liraglutide) or a placebo following their surgery.See study design
What are the potential side effects?
Possible side effects from Liraglutide may include digestive disturbances like nausea and vomiting; rare but serious risks involve thyroid cancer and inflammation of the pancreas. Placebos typically have no active ingredients but can cause perceived side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Agonism of the GLP-1 receptor will Increase weight loss
Secondary outcome measures
Agonism of the GLP-1 receptor will lower LDL-cholesterol
Agonism of the GLP-1 receptor will lower blood pressure.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Sleeve Gastrectomy SaxendaActive Control1 Intervention
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
Group II: Sleeve Gastrectomy PlaceboPlacebo Group1 Intervention
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
Group III: RYGBPlacebo Group1 Intervention
Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,065 Total Patients Enrolled
84 Trials studying Obesity
14,648 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,414,990 Total Patients Enrolled
141 Trials studying Obesity
131,963 Patients Enrolled for Obesity
Adrian VellaPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
University Of Malta (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
6 Previous Clinical Trials
144 Total Patients Enrolled
2 Trials studying Obesity
89 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to liraglutide or any of the ingredients in the medication.You or someone in your family has had a specific type of thyroid cancer called medullary thyroid carcinoma or a condition called Multiple Endocrine Neoplasia type 2.You are currently taking insulin or a medication called GLP-1 receptor agonist.You have a serious mental health condition that is currently causing problems in your daily life.You have had pancreatitis (inflammation of the pancreas), cholelithiasis (gallstones), or cholecystitis (inflammation of the gallbladder) in the past.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sleeve Gastrectomy Placebo
- Group 2: Sleeve Gastrectomy Saxenda
- Group 3: RYGB
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be involved in this clinical trial at the most?
"Indeed, the clinical trial is recruiting patients as the listing on clinicaltrials.gov shows. The study was first posted on 6/22/2017 with the most recent update on 8/1/2022. They are looking for 75 participants at a single site."
Answered by AI
What indications does Sleeve Gastrectomy Saxenda typically help with?
"Sleeve Gastrectomy Saxenda is a medication used to help patients who want to exercise more, as well as those struggling to control their weight with other forms of treatment, reduce their cardiovascular risks, or manage cardiovascular disease."
Answered by AI
Are there any more spots left for patients in this clinical trial?
"The study is still recruiting patients, based on the most recent update on clinicaltrials.gov. This information was originally posted on June 22nd, 2017, and the most recent edit was on August 1st, 2022."
Answered by AI
Could I potentially join this ongoing research project?
"This obesity clinical trial, which is hosted at the Mayo Clinic, is looking for 75 patients that meet the following qualifications: between 20-65 years old, have received nutrition counseling at the Mayo Clinic, been cleared for bariatric surgery, no other physical illness that will interfere with weight loss post-surgery."
Answered by AI
Are adults above the age of 30 years old being recruited for this trial?
"As this study's inclusion criteria stipulate, the minimum age of patients that can enroll is 20 while the maximum age is 65."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
What site did they apply to?
Mayo Clinic in Rochester
Why did patients apply to this trial?
Previous drugs failed to resolve wright issues.
PatientReceived no prior treatments
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