An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384605

Enrollment

1000

Registered

2006-10-06

Start date

2006-10-31

Completion date

2008-12-31

Last updated

2015-03-13

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

Conditions

Obesity

Brief summary

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Interventions

DRUGtaranabant

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

DRUGplacebo

Placebo capsule once daily. Treatment for 52 weeks.

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

* Male or female, 18 years of age or older, with Body Mass Index (BMI) 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). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea * Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion criteria

* History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures * Screening systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg

Design outcomes

Primary

Measure	Time frame
Body weight after 52 weeks of treatment	52 weeks

Secondary

Measure	Time frame
Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment	52 weeks

Outcome results

None listed

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