DRUG
Saxenda: Underlying Mechanisms and Clinical Outcomes
Status
Active, not recruiting
Phase
Phase 4
Enrollment
28
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Full detailed description
The effect of treatment with the study drug Liraglutide, a recently discovered GLP-1 receptor agonist, on centers of the brain that control appetite and food intake will be studied in detail.
Interventions
Treatment arms and agents.
OTHER
Placebo
Timeline
From registration to results.
First posted
Oct 26, 2016
Study start
Nov 2016
Primary completion
Jun 2027
Study completion
Jun 2027
Results posted
Not reported
Registry updated
May 1, 2026
Outcomes
What the study measures.
Primary outcomes
BOLD response to food cues
Time frame · 5 weeks
effect size of BOLD response to food cues in the brain
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * 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). Exclusion Criteria: 1. Women who are breastfeeding, pregnant, or wanting to become pregnant. 2. Women using metal IUD 3. 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. 4. Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease 5. Moderate, or severe hepatic impairment 6. Hypersensitivity to the active substance or any of the excipients in liraglutide 7. History of diabetic ketoacidosis 8. Congestive heart failure 9. EKG abnormalities (as listed above) 10. Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc 11. Gastroparesis 12. Pancreatitis 13. Gallstones- as they may cause increased risk of pancreatitis 14. 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. 15. Untreated thyroid disease like hypothyroidism or hyperthyroidism 16. Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc). 17. Subjects on any oral anti-diabetic agent except metformin 18. Personal or family history of MEN II or medullary thyroid cancer 19. 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.) 20. 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 21. Anxiety of small spaces and/or claustrophobia 22. Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function) 23. Significant sensory or motor impairment 24. Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation 25. Subjects with neurological or psychological problems which may interfere with or complicate testing (e.g. presence of titubation) 26. Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan. 27. Subjects who cannot adhere to the experimental protocol for any reason 28. Anemia with Hgb less than 10 29. Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc) 30. Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc 31. Any cancers or lymphoma 32. Eating disorders like anorexia, bulimia 33. Severe hypertriglyceridemia (triglycerides \>500 mg/dl) 34. Weight loss surgery or gastrectomy 35. Any changes in medications that affect brain function, e.g. anti-depressants, anti-psychotics, anti-anxiety, anti-seizure medications, antihypertensives etc (subjects should remain on same medication/ same dose during the time of the entire study). 36. Vegetarians- as food images presented will include numerous non-vegetarian items and thus will not be appealing as high calorie food items. 37. Suicidality, as measured by the MSSI at screening visit.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Beth Israel Deaconess Medical Center General Clinical Research Center
Boston, Massachusetts, United States
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.