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GLP-1 Receptor Agonist

liraglutide for Obesity

Beth Israel Deaconess Medical Center General Clinical Research Center, Boston, MA
liraglutide +1 morePhase 4Waitlist AvailableResearch Sponsored by Beth Israel Deaconess Medical Center

Study Summary

This trial will study the effect of a drug called Liraglutide on areas of the brain that control appetite and food intake.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

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 • NCT02008682
15%
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
FDA approved

Find a site

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
816 Previous Clinical Trials
6,993,078 Total Patients Enrolled
20 Trials studying Obesity
602 Patients Enrolled for Obesity

Media Library

Liraglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02944500 — Phase 4
Obesity Research Study Groups: Liraglutide followed by placebo, Placebo followed by liraglutide
Obesity Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT02944500 — Phase 4
Liraglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02944500 — Phase 4
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 !
Patient
Recent research and studies
Cardiovascular DiabetologyJournal
Short-term Treatment with High Dose Liraglutide Improves Lipid and Lipoprotein Profile and Changes Hormonal Mediators of Lipid Metabolism in Obese Patients with No Overt Type 2 Diabetes Mellitus: A Randomized, Placebo-controlled, Cross-over, Double-blind Clinical Trial
Peradze, Natia, Olivia M. Farr, Nikolaos Perakakis, Iolanda Lázaro, Aleix Sala-Vila, and Christos S. Mantzoros. 2019. “Short-term Treatment with High Dose Liraglutide Improves Lipid and Lipoprotein Profile and Changes Hormonal Mediators of Lipid Metabolism in Obese Patients with No Overt Type 2 Diabetes Mellitus: A Randomized, Placebo-controlled, Cross-over, Double-blind Clinical Trial”. Cardiovascular Diabetology. Springer Science and Business Media LLC. doi:10.1186/s12933-019-0945-7.
clinicaltrials.govStudy
Saxenda: Underlying Mechanisms and Clinical Outcomes
Christos Mantzoros 2016. "Saxenda: Underlying Mechanisms and Clinical Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02944500.
~4 spots leftby Dec 2024
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