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Predictors of Lorcaserin-Induced Weight Loss

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Columbia University

Status and phase

Terminated
Phase 4

Conditions

Overweight and Obesity

Treatments

Drug: Belviq
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03353220
2R01DK093920 (U.S. NIH Grant/Contract)
AAAR1622

Details and patient eligibility

About

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).

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

32 participants in 2 patient groups

Arm A
Experimental group
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.
Treatment:
Drug: Placebo
Drug: Belviq
Arm B
Experimental group
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.
Treatment:
Drug: Placebo
Drug: Belviq

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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