Predictors of Lorcaserin-Induced Weight Loss

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2020-02-14

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Belviq

Intervention Type DRUG

Belviq is an oral drug

Placebo

Intervention Type DRUG

The placebo is made to mimic Belviq, but does not contain any active drug

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.

Group Type EXPERIMENTAL

Belviq

Intervention Type DRUG

Belviq is an oral drug

Placebo

Intervention Type DRUG

The placebo is made to mimic Belviq, but does not contain any active drug

Interventions

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Belviq

Belviq is an oral drug

Intervention Type DRUG

Placebo

The placebo is made to mimic Belviq, but does not contain any active drug

Intervention Type DRUG

Other Intervention Names

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Lorcaserin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes