Your session is about to expire
← Back to Search
GLP-1 Receptor Agonist
Saxenda for Obesity
Phase 4
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis)
Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights
Study Summary
This trial will study the effect of a drug called Liraglutide on areas of the brain that control appetite and food intake.
Who is the study for?
This trial is for adults with obesity (BMI >30 or >27 with related health issues like high blood pressure). It's not for those who are pregnant, breastfeeding, planning to get pregnant, have severe kidney or liver problems, heart failure, certain mental health conditions, uncontrolled infections like HIV/hepatitis, history of pancreatitis or thyroid disease. People with metal implants that affect MRI scans or weigh over 330lbs can't join.Check my eligibility
What is being tested?
The study tests Liraglutide against a placebo to see its effects on brain centers controlling hunger and food intake. Participants will be randomly assigned to receive either the drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Liraglutide may cause side effects such as digestive issues (nausea, vomiting), low blood sugar levels especially when combined with other diabetes medications, increased heart rate and potential risk of pancreatitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am obese with a BMI over 30, or over 27 with related health issues.
Select...
I am obese with a BMI over 30, or over 27 with related health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BOLD response to food cues
Side effects data
From 2014 Phase 4 trial • 368 Patients • NCT0200868215%
Nausea
11%
Decreased appetite
8%
Diarrhoea
6%
Lipase increased
1%
Sudden hearing loss
1%
Bronchitis
1%
Diabetic ketoacidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Sitagliptin
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo followed by liraglutideExperimental Treatment2 Interventions
Participants will receive placebo with dose titration (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of liraglutide for the same amount of time.
Group II: Liraglutide followed by placeboExperimental Treatment2 Interventions
Participants will receive liraglutide with dose titration over 5 weeks (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of placebo for the same amount of time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
liraglutide
2004
Completed Phase 4
~4610
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,308 Total Patients Enrolled
21 Trials studying Obesity
752 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am obese with a BMI over 30, or over 27 with related health issues.I am not changing my hormonal birth control dose during the study.My kidney function is significantly impaired.I have gallstones.You are a woman using a metal IUD for birth control.I am currently pregnant, breastfeeding, or planning to become pregnant.I drink no more than two drinks a day if I'm a man, or one if I'm a woman.I have epilepsy that could make MRI scans risky for me.I have had weight loss surgery or part of my stomach removed.My brain-related medications have not changed recently.My liver is not working well.I do not have any uncontrolled infectious diseases like HIV or hepatitis.I do not have any uncontrolled hormone-related conditions.I am currently taking warfarin, steroids, or hormone treatments.I have major issues with feeling or moving parts of my body.I have been diagnosed with cancer or lymphoma.You have neurological or psychological issues that could affect the testing process or make it more complicated.I have an eating disorder such as anorexia or bulimia.I am taking diabetes medication other than metformin.I feel anxious in small spaces or have claustrophobia.I have a condition like inflammatory bowel disease or rheumatoid arthritis.I have been diagnosed with congestive heart failure.I have had diabetic ketoacidosis in the past.I do not have uncontrolled heart or circulation problems, nor issues with sweating.I have untreated thyroid disease.You are allergic to liraglutide or any of its ingredients.I have pancreatitis.I am obese with a BMI over 30, or over 27 with related health issues.I have been diagnosed with gastroparesis.I or my family have a history of MEN II or medullary thyroid cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Liraglutide followed by placebo
- Group 2: Placebo followed by liraglutide
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Obesity Patient Testimony for trial: Trial Name: NCT02944500 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity available to participants in this experiment?
"This investigation is no longer seeking participants, as the trial was first posted on November 1st 2016 and last updated on July 18th 2022. However, clinicaltrials.gov lists 992 other studies that are currently open for enrolment."
Answered by AI
Are there any potential risks to utilizing liraglutide as a treatment?
"The safety of liraglutide attained a score of 3 on our evaluation metrics, as it is currently in its fourth phase and has already been approved."
Answered by AI
What qualifications must one meet in order to take part in this medical research?
"This research initiative is seeking 28 individuals with obesity to participate. To qualify, applicants must have a BMI of more than 30 kg/m2 or greater than 27kg/m2 and any accompanying comorbidities (such as insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease hyperuricemia and gout). The ages accepted range from 18-100 years old."
Answered by AI
Up to how many participants can join this clinical experiment?
"At present, this trial is not enrolling new patients. Initially posted on November 1st 2016 and last updated on July 18th 2022, it does not currently offer any opportunities for participation. However, if you are searching for other clinical trials to consider joining , there are 957 studies related to obesity that have open positions as well as 35 trails utilizing liraglutide which are actively recruiting participants."
Answered by AI
Is the demographic for this research project limited to participants under 35 years of age?
"According to the qualifications for this trial, those aged between 18 and 100 are eligible to apply. Additionally, there exist 208 clinical trials specifically tailored towards minors and 621 catered towards elderly patients."
Answered by AI
What therapeutic applications has liraglutide been found to be useful for?
"liraglutide is widely prescribed to treat physical activity, as well as inadequate control on monotherapy, cardiovascular risk reduction, and coronary vascular disease."
Answered by AI
Who else is applying?
What state do they live in?
New York
Rhode Island
Georgia
How old are they?
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center General Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’m 67 years old have hypothyroidism, steadily gaining weight for 15 years !
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger