Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this protocol is to investigate the effect of treatment with the study drug Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food intake.
Eligibility Criteria
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.Inclusion Criteria
I am obese with a BMI over 30, or over 27 with related health issues.
I am obese with a BMI over 30, or over 27 with related health issues.
Exclusion Criteria
I am not changing my hormonal birth control dose during the study.
My kidney function is significantly impaired.
I have gallstones.
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Participant Groups
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.
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.
Liraglutide is already approved in United States, United States, European Union, European Union for the following indications:
🇺🇸 Approved in United States as Victoza for:
- Type 2 diabetes mellitus treatment
- Cardiovascular risk reduction in adults with type 2 diabetes and heart disease
🇺🇸 Approved in United States as Saxenda for:
- Weight loss treatment in adults and children aged 12 and older with obesity
🇪🇺 Approved in European Union as Victoza for:
- Type 2 diabetes mellitus treatment
- Cardiovascular risk reduction in adults with type 2 diabetes and heart disease
🇪🇺 Approved in European Union as Saxenda for:
- Weight loss treatment in adults and children aged 12 and older with obesity
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical Center General Clinical Research CenterBoston, MA
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Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical CenterLead Sponsor