NCT00603291

Brief Summary

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Dec 2007

Typical duration for phase_3 obesity

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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 7, 2013

Completed
Last Updated

October 2, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

January 17, 2008

Results QC Date

January 4, 2013

Last Update Submit

September 19, 2019

Conditions

Obesity

Keywords

obesityweight losslorcaserinAPD356BLOOM-DMhypertensiondyslipidemiasleep apneaglucose tolerancecardiovascular diseaseArena

Outcome Measures

Primary Outcomes (1)

  • Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52

    The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

    Baseline and Week 52

Secondary Outcomes (1)

  • Percent Change in Body Weight From Baseline to Week 52

    Baseline and Week 52

Study Arms (3)

Lorcaserin 10 mg QD

EXPERIMENTAL

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Drug: Lorcaserin 10 mg once daily (QD)

Lorcaserin 10 mg BID

EXPERIMENTAL

Lorcaserin 10 mg tablet each morning and evening

Drug: Lorcaserin 10 mg twice a day (BID)

Matching Placebo

PLACEBO COMPARATOR

Matching placebo tablet each morning and evening

Drug: Matching Placebo

Interventions

Lorcaserin 10 mg once daily (QD)DRUG

Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.

Also known as: APD356
Lorcaserin 10 mg QD
Lorcaserin 10 mg twice a day (BID)DRUG

Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.

Also known as: APD356
Lorcaserin 10 mg BID
Matching PlaceboDRUG

Matching placebo tablet each morning and evening for a duration of 52 weeks.

Matching Placebo

Eligibility Criteria

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

You may qualify if:

  • Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
  • Body mass index (BMI) 27 to 45 kg/m2, inclusive.
  • Ability to complete a 1 year study

You may not qualify if:

  • Pregnancy
  • Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
  • History of symptomatic heart valve disease
  • Serious or unstable current or past medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arena Pharmaceuticals, Inc.

San Diego, California, 92121, United States

Location

Related Publications (7)

  • Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27.

    PMID: 28345809DERIVED

  • Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.

    PMID: 27888609DERIVED

  • Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.

    PMID: 27659698DERIVED

  • Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18.

    PMID: 27389084DERIVED

  • Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.

    PMID: 27206567DERIVED

  • Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.

    PMID: 23661689DERIVED

  • O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.

    PMID: 22421927DERIVED

Related Links

MeSH Terms

Conditions

ObesityWeight LossHypertensionDyslipidemiasSleep Apnea SyndromesCardiovascular Diseases

Interventions

lorcaserinBID protein, human

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Eisai Medical Information
Organization
Eisai Inc.
esi_medinfo@eisai.com
+1-888-274-2378

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 29, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2010

Study Completion

October 1, 2010

Last Updated

October 2, 2019

Results First Posted

February 7, 2013

Record last verified: 2019-08

Locations

US(1)