Status:

TERMINATED

Predictors of Lorcaserin-Induced Weight Loss

Lead Sponsor:

Columbia University

Collaborating Sponsors:

New York State Psychiatric Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Overweight and Obesity

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

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 ...

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 t...

Eligibility Criteria

Inclusion

  • Body Mass Index (BMI) 28-40

Exclusion

  • 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

Key Trial Info

Start Date :

January 3 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 14 2020

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT03353220

Start Date

January 3 2018

End Date

February 14 2020

Last Update

March 27 2024

Active Locations (1)

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1

Columbia University Medical Center

New York, New York, United States, 10032