CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 604 enrolled
Drug / intervention
Lorcaserin 10 mg once daily (QD) +2 moredrug
Likely dose
Lorcaserin 10 mg once daily (QD)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00603291
NCT00603291Phase 3Completed
CompareCT.gov

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)

Eisai Inc.·interventional·Posted Jan 29, 2008·Updated Oct 2, 2019

In Brief

A Phase 3 clinical trial evaluating Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID), and 1 other intervention for Obesity. Completed, enrolled 604 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2008
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.4 years ago

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.

Lorcaserin 10 mg twice a day (BID)drug

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

Matching Placebodrug

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