NCT02400359

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
12mo left

Started Oct 2014

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2014Jun 2027

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

12.7 years

First QC Date

January 12, 2015

Last Update Submit

April 27, 2026

Conditions

ObesityWeight Loss

Keywords

fMRIMagnetic Resonance ImagingendocrinologyMRIobesityweight losslorcaserin

Outcome Measures

Primary Outcomes (1)

  • fMRI (Functional changes in the brain)

    28 days

Secondary Outcomes (2)

  • Body Composition (DEXA)

    6 months

  • Metabolic Rate (Resting Metabolic Rate (RMR)

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to either placebo or Lorcaserin HCl.

Drug: Placebo

Active

ACTIVE COMPARATOR

Subjects will be randomized to either placebo or Lorcaserin HCl.

Drug: Lorcaserin HCl

Interventions

Lorcaserin HClDRUG

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

Also known as: Belviq
Active
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 27385157DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Christos S Mantzoros, MD DSc

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 12, 2015

First Posted

March 27, 2015

Study Start

October 1, 2014

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)