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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

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).

Condition or disease Intervention/treatment Phase
Overweight and Obesity Drug: Belviq Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353220


Contacts
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Contact: Cara Dimino, BSPH 212-305-3725 cd2922@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Cara Dimino, BSPH    212-305-3725    cd2922@cumc.columbia.edu   
Principal Investigator: Sharon Wardlaw, MD         
Sponsors and Collaborators
Columbia University
New York State Psychiatric Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sharon Wardlaw, MD Columbia University

Additional Information:
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Responsible Party: Sharon Wardlaw, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03353220     History of Changes
Other Study ID Numbers: AAAR1622
2R01DK093920 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sharon Wardlaw, Columbia University:
Overweight
Obesity
Weight Loss
Lorcaserin
Healthy Volunteers
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes