Predictors of Lorcaserin-Induced Weight Loss
Primary Purpose
Overweight and Obesity
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Belviq
Placebo
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Weight Loss, Lorcaserin, Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) 28-40
Exclusion Criteria:
- Any clinically significant or relevant medical condition, including:
- Diabetes
- Uncontrolled Hypertension
- Heart disease
- Bleeding disorder
- Kidney or liver dysfunction
- Neurologic disease
- Psychiatric or eating disorders
- Pregnancy or breastfeeding
- Use of tobacco or opiates
- History of alcohol or drug abuse
- Recent weight change +/- 5%
- Medications that affect body weight
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days.
Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq)10 mg twice a day for 7 days.
Outcomes
Primary Outcome Measures
Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo
This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.
Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo
This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations.
Secondary Outcome Measures
CSF Concentrations of ß-endorphin
Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin.
Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo
This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.
Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo
This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.
Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo
This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations.
Insulin Level
This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.
Full Information
NCT ID
NCT03353220
First Posted
November 21, 2017
Last Updated
August 29, 2021
Sponsor
Columbia University
Collaborators
New York State Psychiatric Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03353220
Brief Title
Predictors of Lorcaserin-Induced Weight Loss
Official Title
Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
New York State Psychiatric Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This two-phase study aims to explore ways to predict who will respond well to the weight loss drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy. Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo followed by treatment with lorcaserin for 24 weeks (phase 2).
Detailed Description
In phase 1, at Weeks 1 and 5, participants will take the weight loss drug lorcaserin or placebo for 7 days. At Week 5 participants will receive whichever treatment they did not receive at Week 1. At the end of Weeks 1 and 5, participants will have a lumbar puncture (spinal tap) to collect cerebrospinal fluid (CSF) for neuropeptide and hormone analyses, including proopiomelanocortin (POMC), Agouti-related protein (AgRP) and cortisol. Blood will also be obtained for neuropeptide and hormone analyses. Breakfast will be served to participants who will then complete an eating behavior profile. A laboratory test meal will be performed 4h after breakfast.
After completing both the 7 day lorcaserin and placebo studies, participants will then continue on Phase 2 of the study, which includes treatment with lorcaserin for 24 weeks. Subjects will receive nutritional counseling to reduce their daily caloric intake to 600 kcal below their calculated caloric requirement and will be encourage to exercise moderately for 30 minutes daily. Participants will visit the clinic monthly during the 24 week study period for nutritional counseling, review of food diaries, vital signs and safely labs. Blood will also be obtained for neuropeptide peptide and hormone analyses. At the end of the 24 week period subjects will come for a final study visit, including a lumbar puncture, blood sample, breakfast, an eating behavior profile and a test meal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Weight Loss, Lorcaserin, Healthy Volunteers
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq)10 mg twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Belviq
Other Intervention Name(s)
Lorcaserin
Intervention Description
Belviq is an oral drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo is made to mimic Belviq, but does not contain any active drug
Primary Outcome Measure Information:
Title
Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo
Description
This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.
Time Frame
First test meal and follow-up test meal (approximately up to 5 weeks)
Title
Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo
Description
This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations.
Time Frame
Baseline, up to 5 weeks
Secondary Outcome Measure Information:
Title
CSF Concentrations of ß-endorphin
Description
Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin.
Time Frame
Baseline, up to 5 weeks
Title
Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo
Description
This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.
Time Frame
Baseline, up to 5 weeks
Title
Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo
Description
This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.
Time Frame
Baseline, up to 5 weeks
Title
Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo
Description
This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations.
Time Frame
Baseline, up to 5 weeks
Title
Insulin Level
Description
This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.
Time Frame
Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body Mass Index (BMI) 28-40
Exclusion Criteria:
Any clinically significant or relevant medical condition, including:
Diabetes
Uncontrolled Hypertension
Heart disease
Bleeding disorder
Kidney or liver dysfunction
Neurologic disease
Psychiatric or eating disorders
Pregnancy or breastfeeding
Use of tobacco or opiates
History of alcohol or drug abuse
Recent weight change +/- 5%
Medications that affect body weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Wardlaw, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://druginfo.nlm.nih.gov/drugportal/name/lorcaserin%20hcl
Description
NIH - lorcaserin HCl
URL
https://projectreporter.nih.gov/project_info_description.cfm?projectnumber=5R01DK080003-02
Description
Study Grant
URL
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022529
Description
FDA approval Belviq
Learn more about this trial
Predictors of Lorcaserin-Induced Weight Loss
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