Predictors of Lorcaserin-Induced Weight Loss

Overweight and Obesity Clinical Trial

Official title:

Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03353220
• Other study ID #: AAAR1622
• Secondary ID: 2R01DK093920
• Status: Terminated
• Phase: Phase 4
• Start date: January 3, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Drug:
• Belviq
Belviq is an oral drug
• Placebo
The placebo is made to mimic Belviq, but does not contain any active drug

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sideri Gugger A, Dimino C, Panigrahi SK, Mayer L, Smiley RM, Korner J, Wardlaw SL. Defining Predictors of Weight Loss Response to Lorcaserin. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2262-2271. doi: 10.1210/clinem/dgad139. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo	This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.	First test meal and follow-up test meal (approximately up to 5 weeks)
Primary	Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo	This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations.	Baseline, up to 5 weeks
Secondary	CSF Concentrations of ß-endorphin	Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin.	Baseline, up to 5 weeks
Secondary	Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo	This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.	Baseline, up to 5 weeks
Secondary	Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo	This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.	Baseline, up to 5 weeks
Secondary	Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo	This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations.	Baseline, up to 5 weeks
Secondary	Insulin Level	This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.	Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.

External Links

•   FDA approval Belviq
•   NIH - lorcaserin HCl
•   Study Grant