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Saxenda: Underlying Mechanisms and Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT02944500
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: liraglutide Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Saxenda: Underlying Mechanisms and Clinical Outcomes
Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide followed by placebo
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.
Drug: liraglutide
Other Name: Saxenda

Other: Placebo
Experimental: Placebo followed by liraglutide
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.
Drug: liraglutide
Other Name: Saxenda

Other: Placebo



Primary Outcome Measures :
  1. BOLD response to food cues [ Time Frame: 5 weeks ]
    effect size of BOLD response to food cues in the brain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944500


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center General Clinical Research Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lesya Zaichenko, BS    617-667-1656    lzaichen@bidmc.harvard.edu   
Principal Investigator: Christos S Mantzoros, MD, ScD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02944500     History of Changes
Other Study ID Numbers: 2015P000327
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.

Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
Brain
Liraglutide
MRI

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists