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Predictors of Lorcaserin-Induced Weight Loss

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ClinicalTrials.gov Identifier: NCT03353220
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
New York State Psychiatric Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sharon Wardlaw, Columbia University

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Food Intake (average calories consumed during test meal) [ Time Frame: up to 3 years ]
Mean differences in food intake during a laboratory test meal after lorcaserin for one week compared to placebo. Prediction of long-term lorcaserin induced weight loss using the short-term differences in calories consumed during the test meal.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03353220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml) [ Time Frame: up to 3 years ]
    Mean differences in POMC concentrations (fmol/ml) in CSF after lorcaserin for one week compared to placebo. Prediction of long-term lorcaserin induced weight loss using short-term differences in CSF POMC concentrations.
  • Mean Agouti-related protein (AgRP) concentrations (fmol/ml) in CSF [ Time Frame: up to 3 years ]
    Mean differences in AgRP concentrations (fmol/ml) in CSF after lorcaserin for one week compared to placebo. Prediction of long-term lorcaserin induced weight loss using short-term differences in AgRP concentrations.
  • Mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood [ Time Frame: up to 3 years ]
    Mean differences in AgRP concentrations (fmol/ml) in blood after lorcaserin for one week compared to placebo. Prediction of long-term lorcaserin induced weight loss using short-term differences in AgRP concentrations.
  • Mean Cortisol concentrations (ng/ml) in CSF [ Time Frame: up to 3 years ]
    Mean differences in cortisol concentrations(ng/ml) in CSF after lorcaserin for one week compared to placebo. Prediction of long-term lorcaserin induced weight loss using short-term differences in cortisol concentrations.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predictors of Lorcaserin-Induced Weight Loss
Official Title  ICMJE Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • Drug: Belviq
    Belviq is an oral drug
    Other Name: Lorcaserin
  • Drug: Placebo
    The placebo is made to mimic Belviq, but does not contain any active drug
Study Arms  ICMJE
  • Experimental: Arm A
    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.
    Interventions:
    • Drug: Belviq
    • Drug: Placebo
  • Experimental: Arm B
    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.
    Interventions:
    • Drug: Belviq
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cara Dimino, BSPH 212-305-3725 cd2922@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353220
Other Study ID Numbers  ICMJE AAAR1622
2R01DK093920 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sharon Wardlaw, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • New York State Psychiatric Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Sharon Wardlaw, MD Columbia University
PRS Account Columbia University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP