Predictors of Lorcaserin-Induced Weight Loss

NCT03353220 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: AAAR16222R01DK093920
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Weight Loss; Lorcaserin; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• CSF Concentrations of ß-endorphin

  Baseline, up to 5 weeks

• Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo

  Baseline, up to 5 weeks

• Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo

  Baseline, up to 5 weeks

• Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo

  Baseline, up to 5 weeks

• Insulin Level

  Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.

Study Arms (2)

Arm A

EXPERIMENTAL

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; Drug: Placebo

Arm B

EXPERIMENTAL

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; Drug: Placebo

Interventions

Belviq DRUG

Belviq is an oral drug

Also known as: Lorcaserin

Arm A; Arm B

Placebo DRUG

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) 28-40

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York State Psychiatric Institute: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related 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.

  PMID: 36897161 RESULT

Related Links

• NIH - lorcaserin HCl
• FDA approval Belviq

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

Study was stopped prematurely during Phase 2 due to lack of drug supply.

Results Point of Contact

• Title: Sharon Wardlaw, MD
• Organization: Columbia University

sw22@cumc.columbia.edu

212-305-3725

Study Officials

• Sharon Wardlaw, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: January 3, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: March 27, 2024
• Results First Posted: September 23, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)