ObesityPhase 4NCT02944500
Saxenda: Underlying Mechanisms and Clinical Outcomes
A Phase 4 study testing liraglutide in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 37Show fewer
- 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)
- Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan.
- Subjects who cannot adhere to the experimental protocol for any reason
- Anemia with Hgb less than 10
- Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc)
- Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc
- Any cancers or lymphoma
- Eating disorders like anorexia, bulimia
- Severe hypertriglyceridemia (triglycerides >500 mg/dl)
- Weight loss surgery or gastrectomy
- 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).
- Vegetarians- as food images presented will include numerous non-vegetarian items and thus will not be appealing as high calorie food items.
- Suicidality, as measured by the MSSI at screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center General Clinical Research Center
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- liraglutide, Placebo
- Keywords
- Brain, Liraglutide, MRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Saxenda
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide followed by placebo | Experimental | 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. Receives: Drug: liraglutide; Other: Placebo |
| Placebo followed by liraglutide | Experimental | 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. Receives: Drug: liraglutide; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response to food cues
effect size of BOLD response to food cues in the brain
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Mantzoros, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944500
- Sponsor's protocol ID
- 2015P000327
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2016
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
Publications
Stefanakis K, Gutierrez de Pineres V, Veeragandham P, Mantzoros CS. Proteomic effects of short-term liraglutide vs. placebo in a blinded crossover RCT: Implications for efficacy, safety, and comparison with semaglutide. Metabolism. 2026 Apr;177:156493. doi: 10.1016/j.metabol.2026.156493. Epub 2026 Jan 7.
PubMed 41513169Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.
PubMed 36375643Peradze N, Farr OM, Perakakis N, Lazaro I, Sala-Vila A, Mantzoros CS. 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. Cardiovasc Diabetol. 2019 Oct 31;18(1):141. doi: 10.1186/s12933-019-0945-7.
PubMed 31672146
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saxenda: Underlying Mechanisms and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02944500
- Acronym / sponsor ID
- 2015P000327
- Conditions
- Obesity
- Keywords
- Brain, Liraglutide, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide followed by placebo | Experimental | Drug: liraglutide, Other: PlaceboParticipants 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. |
| Placebo followed by liraglutide | Experimental | Drug: liraglutide, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: Saxenda | Drug | Liraglutide followed by placebo, Placebo followed by liraglutide |
| Placebo | Other | Liraglutide followed by placebo, Placebo followed by liraglutide |
Primary outcome
BOLD response to food cues
Time frame: 5 weeks
effect size of BOLD response to food cues in the brain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41513169Stefanakis K, Gutierrez de Pineres V, Veeragandham P, Mantzoros CS. Proteomic effects of short-term liraglutide vs. placebo in a blinded crossover RCT: Implications for efficacy, safety, and comparison with semaglutide. Metabolism. 2026 Apr;177:156493. doi: 10.1016/j.metabol.2026.156493. Epub 2026 Jan 7.
- Derived from this study: PubMed 36375643Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.
- Derived from this study: PubMed 31672146Peradze N, Farr OM, Perakakis N, Lazaro I, Sala-Vila A, Mantzoros CS. 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. Cardiovasc Diabetol. 2019 Oct 31;18(1):141. doi: 10.1186/s12933-019-0945-7.
- Individual participant dataSharing planned: No. Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response to food cues (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02944500, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.