NCT00829140

Brief Summary

The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 12, 2019

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

January 22, 2009

Last Update Submit

September 11, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment.

Secondary Outcomes (1)

  • To assess the ongoing safety of lorcaserin

Study Arms (2)

Placebo BID

PLACEBO COMPARATOR
Drug: Placebo

Lorcaserin 10mg BID

EXPERIMENTAL
Drug: Lorcaserin 10mg BID

Interventions

PlaceboDRUG
Placebo BID
Lorcaserin 10mg BIDDRUG
Lorcaserin 10mg BID

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged between 18 and 65 years (inclusive)
  • Body Mass Index (BMI) is 27.0 to 45.0 kg/m2, inclusive
  • Able to give signed informed consent
  • Ambulatory and able to perform exercise program (Arena Healthy Lifestyle Program, see Appendix 1)
  • Eligible male and female patients must agree not to participate in a conception process
  • Considered to be in stable health in the opinion of the Investigator

You may not qualify if:

  • Prior participation in any study of lorcaserin.
  • Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
  • Clinically significant new illness in the 1 month before screening
  • Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
  • Recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. SSRI's, SNRI's, and other medications must meet washout requirements.
  • Significant dislike or allergy to foods used during the food intake tests
  • History of any of the following cardiovascular conditions:
  • Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 3 months of screening; cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening
  • Unstable angina
  • History of congestive heart failure caused by insufficiency, damage, or stenosis of any heart valve
  • History of pulmonary artery hypertension
  • Positive result of HIV, hepatitis B or hepatitis C screens
  • Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat)
  • Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

    PMID: 24500151DERIVED

  • Martin CK, Redman LM, Zhang J, Sanchez M, Anderson CM, Smith SR, Ravussin E. Lorcaserin, a 5-HT(2C) receptor agonist, reduces body weight by decreasing energy intake without influencing energy expenditure. J Clin Endocrinol Metab. 2011 Mar;96(3):837-45. doi: 10.1210/jc.2010-1848. Epub 2010 Dec 29.

    PMID: 21190985DERIVED

MeSH Terms

Conditions

Obesity

Interventions

lorcaserinBID protein, human

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

February 1, 2010

Last Updated

September 12, 2019

Record last verified: 2010-11

Locations

US(1)