ObesityPhase 3NCT00131391

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

A Phase 3 study testing Comparator: taranabant in people with Obesity, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity
What is being tested?: Comparator: taranabant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,400 participants
Where: No sites listed yet
Study dates: Jul 2005to Dec 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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

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

Conditions: Obesity
Being tested: Comparator: taranabant, Comparator: placebo
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: taranabantDrug
Also called MK0364
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Comparator: placeboDrug
Placebo capsule once daily . 52 week treatment period.

Study groups in NCT00131391
Study group	Role	What they receive
Phase A/B; Arm 1	Placebo comparator	Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 1: MK0364 Pbo capsule once daily. Receives: Drug: Comparator: placebo
Phase A/B: Arm 2	Experimental	Phase A: Arm 2: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily. Receives: Drug: Comparator: taranabant
Phase A/B: Arm 3	Experimental	Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily. Receives: Drug: Comparator: taranabant; Drug: Comparator: placebo
Phase A/B: Arm 4	Experimental	Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily. Receives: Drug: Comparator: taranabant
Phase A/B: Arm 5	Experimental	Phase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily. Receives: Drug: Comparator: taranabant
Phase A/B: Arm 6	Experimental	Phase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily. Receives: Drug: Comparator: taranabant

What is being measured

The primary outcome is the main question the study is designed to answer.

Decreases body weight; prevention of weight regain; safety and tolerability
Measured: 2 Years

Secondary outcomes (1)

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
Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Dec 2008

First posted18 Aug 2005 (estimated)
Study startJul 2005
Primary completionFeb 2008
Study completionDec 2008

Why it stopped: The overall profile does not support development for obesity

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2,400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00131391
Sponsor's protocol ID: 0364-014
Other IDs: 2005_034
Status last verified: Apr 2015
First submitted: 16 Aug 2005
Last updated: 3 Apr 2015
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00131391
Acronym / sponsor ID: 0364-014
Conditions: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The overall profile does not support development for obesity
Enrolment: 2,400 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Feb 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 18 Aug 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Phase A/B; Arm 1	Placebo comparator	Drug: Comparator: placeboPhase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.
Phase A/B: Arm 2	Experimental	Drug: Comparator: taranabantPhase A: Arm 2: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily.
Phase A/B: Arm 3	Experimental	Drug: Comparator: taranabant, Drug: Comparator: placeboPhase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily.
Phase A/B: Arm 4	Experimental	Drug: Comparator: taranabantPhase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily.
Phase A/B: Arm 5	Experimental	Drug: Comparator: taranabantPhase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily.
Phase A/B: Arm 6	Experimental	Drug: Comparator: taranabantPhase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: taranabantAlso: MK0364taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.	Drug	Phase A/B: Arm 2, Phase A/B: Arm 3, Phase A/B: Arm 4, Phase A/B: Arm 5, Phase A/B: Arm 6
Comparator: placeboPlacebo capsule once daily . 52 week treatment period.	Drug	Phase A/B: Arm 3, Phase A/B; Arm 1

Primary outcome

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

1 secondary outcome

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
Time frame: 2 Years

Results and safety

The study was stopped early (reason given: The overall profile does not support development for obesity). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: taranabant in people with Obesity, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The overall profile does not support development for obesity). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreases body weight; prevention of weight regain; safety and tolerability (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00131391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.