A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00131404

Enrollment

2400

Registered

2005-08-18

Start date

2005-09-30

Completion date

2008-12-31

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Interventions

DRUGtaranabant

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.

DRUGComparator: Placebo

Placebo capsule once daily. 52 week treatment period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea

Exclusion criteria

* Patients with serious or unstable current or past medical conditions

Design outcomes

Primary

Measure	Time frame
Decreases body weight; safety and tolerability	156 Weeks

Secondary

Measure	Time frame
Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity	156 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026