Saxenda: Underlying Mechanisms and Clinical Outcomes
Running, not enrolling · Phase 4 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT02944500
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 28
- Starts
- 2016-11-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- Women who are breastfeeding, pregnant, or wanting to become pregnant.
- Women using metal IUD
- Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study.
- Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease
- Moderate, or severe hepatic impairment
- Hypersensitivity to the active substance or any of the excipients in liraglutide
- History of diabetic ketoacidosis
- Congestive heart failure
- EKG abnormalities (as listed above)
- Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc
- Gastroparesis
- Pancreatitis
- Gallstones- as they may cause increased risk of pancreatitis
- Alcohol consumption- the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia.
- Untreated thyroid disease like hypothyroidism or hyperthyroidism
- Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc).
- Subjects on any oral anti-diabetic agent except metformin
- Personal or family history of MEN II or medullary thyroid cancer
- Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.)
- Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos
- Anxiety of small spaces and/or claustrophobia
- Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function)
- Significant sensory or motor impairment
- Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation
- Subjects with neurological or psychological problems which may interfere with or complicate testing (e.g. presence of titubation)
Where it is running
- Beth Israel Deaconess Medical Center General Clinical Research Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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