Clinical trial

Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss

Name

AAAR1622

Description

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).

Trial arms

Trial start

2018-01-03

Estimated PCD

2020-02-14

Trial end

2020-02-14

Status

Terminated

Phase

Early phase I

Treatment

Belviq

Belviq is an oral drug

Arms:

Arm A, Arm B

Other names:

Lorcaserin

Placebo

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

Arms:

Arm A, Arm B

Size

Primary endpoint

Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo

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

Baseline, up to 5 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2024-03-27

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug