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An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)

An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131430
Enrollment
500
Registered
2005-08-18
Start date
2005-08-31
Completion date
2007-05-31
Last updated
2016-06-07

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

Conditions

Obesity and Obesity-related Medical Conditions

Brief summary

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

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

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
No

Inclusion criteria

* Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/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

MeasureTime frame
After 24 weeks, body weight, safety, and tolerabilityAfter 24 weeks

Secondary

MeasureTime frame
After 80 weeks, body weightAfter 80 weeks

Outcome results

None listed

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