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ObesityPhase 4NCT02400359

Lorcaserin in Obesity: Identification of CNS Targets Using fMRI

A Phase 4 study testing Lorcaserin HCl in people with Obesity and Weight Loss, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Weight Loss
What is being tested?
Lorcaserin HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2014to 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 65 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).
  • Additionally, women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child.

Who cannot join

  • Subjects using any other weight loss products (orlistat, phentermine, topiramate, fenfluramine, dexfenfluramine, amphetamines, GLP-1 agonists) or use within 3 months.
  • Women who are breastfeeding, pregnant, or wanting to become pregnant.
  • Women using IUD (intrauterine device)
  • 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
Show all 29Show fewer
  • Hypersensitivity to the active substance or any of the excipients in lorcaserin
  • Congestive heart failure and/or pulmonary hypertension
  • Arrhythmias (bradycardia, tachycardia) and valvular heart diseases
  • Diagnosis of diabetes, defined per ADA criteria as Hba1c > 6.5% and/or fasting glucose > 125 mg/dL and/or random glucose > 200 mg/dL
  • Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc.
  • 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: phosphodiesterase inhibitors, serotonergic medications (e.g. SSRI (selective serotonin reuptake inhibitor), SNRI, MAO (monoamine oxidase) inhibitors, bupropion, tricyclic antidepressants, St. John's Wort), valproic acid, codeine (CYP2D6 inhibition), tamoxifen, timolol, warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc).
  • 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 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
  • Weight loss surgery or gastrectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects.

Read the detailed description

The purpose of this protocol is to investigate the effect of treatment with the study drug, called lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's other metabolic effects. Lorcaserin's effect on the brain will be investigated using functional magnetic resonance imaging (fMRI). Lorcaserin was approved in June 2012 as an addition to a reduced-calorie diet and exercise, for chronic weight management. Previous weight loss drugs, such as fenfluramine, acted throughout the body and caused heart problems. Lorcaserin is different because it only acts on receptors (sites of action) that are found in the brain and does not act on the heart, and thus, has not been shown to cause the heart problems seen in the past.

  1. To examine the effects of the study drug lorcaserin, on the brain, and its impact on food visualization (high fat and low fat images) and interaction with satiety (by measuring during the fasting or fed states) using fMRI. (Satiety is defined as when a person has had enough or too much food and does not want to eat any more, as after finishing a satisfying meal.)
  2. To examine the satiety and weight-reducing effect of lorcaserin using physiological measurements (such as how much weight is lost and how this may affect hormone levels), and its association with changes in fMRI responses and neuropsychological performance. To examine whether the long-term weight reducing effects of lorcaserin can be predicted by early food visualization.
Conditions
Obesity, Weight Loss
Being tested
Lorcaserin HCl, Placebo
Keywords
fMRI, Magnetic Resonance Imaging, endocrinology, MRI, obesity, weight loss, lorcaserin
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lorcaserin HClDrug

    Also called Belviq

    Lorcaserin is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic.

  • PlaceboDrug

    This is a placebo oral pill that is a visual replica of the Lorcaserin medication but with no active ingredients.

Study groups in NCT02400359
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects will be randomized to either placebo or Lorcaserin HCl.
Receives: Drug: Placebo
ActiveActive comparatorSubjects will be randomized to either placebo or Lorcaserin HCl.
Receives: Drug: Lorcaserin HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI (Functional changes in the brain)

    Measured: 28 days

Secondary outcomes (2)

  1. Body Composition (DEXA)

    Changes in body composition will be assessed by the following measurements:

    DEXA (Dual Energy X-Ray Absorptiometry): Body composition and bone density will be measured by DEXA. For the DEXA test, the subject will be lying on an examination bed for about 25 minutes. A small part of the DEXA machine will be recording and moving back and forth about 3 feet above their body. The radiation the subject will get is very small and is much less than what one gets from a regular chest X-Ray.

    Anthropometry: Anthropometry will be performed by a licensed dietician. Measurements include: Height, Weight, umbilical and smallest waist, broadest and iliac hip measurements.

    Measured: 6 months

  2. Metabolic Rate (Resting Metabolic Rate (RMR)

    Resting Metabolic Rate (RMR): RMR is the amount of calories the subject burn without doing any physical work. The subject's RMR will be measured with a commonly used instrument. The subject will be asked to lie quietly in bed and stay awake with a large plastic hood over the subject's head and upper body for about 20 minutes. The subject will breathe normally while the air they breathe out is collected and analyzed.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02400359
Sponsor's protocol ID
2014P000196
Status last verified
Apr 2026
First submitted
12 Jan 2015
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Farr OM, Upadhyay J, Gavrieli A, Camp M, Spyrou N, Kaye H, Mathew H, Vamvini M, Koniaris A, Kilim H, Srnka A, Migdal A, Mantzoros CS. Lorcaserin Administration Decreases Activation of Brain Centers in Response to Food Cues and These Emotion- and Salience-Related Changes Correlate With Weight Loss Effects: A 4-Week-Long Randomized, Placebo-Controlled, Double-Blind Clinical Trial. Diabetes. 2016 Oct;65(10):2943-53. doi: 10.2337/db16-0635. Epub 2016 Jul 6.

    PubMed 27385157

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lorcaserin HCl in people with Obesity and Weight Loss, 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 2 inclusion and 29 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. Some participants in this study may receive a placebo. 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?

fMRI (Functional changes in the brain) (time frame: 28 days). 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 NCT02400359, which also lists 1 linked publication.

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.

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