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Trial · Interventional

Active, not recruitingPhase 4Registry data

Saxenda: Underlying Mechanisms and Clinical Outcomes

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
Beth Israel Deaconess Medical Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Nov 2016
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
First posted
26 Oct 2016 (estimated)
Last update posted
1 May 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022202420262028
  1. Ph 4

    Saxenda: Underlying Mechanisms and Clinical Outcomes

    NCT02944500

    Nov 2016 to est. Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • PlaceboOther

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. BOLD response to food cues

    Time frame · 5 weeks

    Registry description

    effect size of BOLD response to food cues in the brain

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2026

19 results

Proteomic effects of short-term liraglutide vs. placebo in a blinded crossover RCT: Implications for efficacy, safety, and comparison with semaglutide.

Stefanakis et al. 2026Metabolism: clinical and experimentalcited by 3

PMID 41513169DOI 10.1016/j.metabol.2026.156493PUB-41513169

Full text at the publisher19 results

Indexing hint: Randomized controlled trial · 2023

5 results

Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity.

Angelidi et al. 2023Metabolism: clinical and experimentalcited by 47

PMID 36375643DOI 10.1016/j.metabol.2022.155346PUB-36375643

Full text at the publisher5 results

Indexing hint: Randomized controlled trial · 2019

10 results

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 et al. 2019Cardiovascular diabetologycited by 44

PMID 31672146PMC6823961DOI 10.1186/s12933-019-0945-7PUB-31672146

CC BY10 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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