A Study of MK0364 in Obese Patients (0364-014)

A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00131391

Enrollment

2400

Registered

2005-08-18

Start date

2005-07-31

Completion date

2008-12-31

Last updated

2015-04-03

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

Conditions

Obesity

Brief summary

A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

Interventions

DRUGComparator: taranabant

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 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

* Body Mass Index (BMI) between 30-43 kg/m2

Exclusion criteria

* History of major psychiatric disorder * History of seizures or at high risk of developing seizures * Blood pressure greater than 160/100 * Fasting blood glucose greater than 126 mg/dL * Triglycerides greater than 600 mg/dL

Design outcomes

Primary

Measure	Time frame
Decreases body weight; prevention of weight regain; safety and tolerability	2 Years

Secondary

Measure	Time frame
Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity	2 Years

Outcome results

None listed

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