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A Weight Loss Study in Overweight Men and Women

NCT00993421 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2011-06-03

Study results available
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Summary

The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.

Conditions

Interventions

DRUG

LY377604

Given daily, orally for 24 weeks

DRUG

Sibutramine

given daily, orally for 24 weeks

DRUG

Metoprolol

given daily, orally for 24 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).

DRUG

Placebo sibutramine

given daily, orally for 24 weeks

DRUG

Placebo Metoprolol

given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)

DRUG

Placebo LY377604

given daily, orally for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993421 on ClinicalTrials.gov