ObesityPhase 3NCT00420589
A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
A Phase 3 study testing taranabant in people with Obesity, run by Merck Sharp & Dohme LLC.
Trial summary
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- taranabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- Patient is male or female >=18 and <= 65 years of age
- Patient understands the study procedures and alternative treatments available
- Patient is able to read, understand and complete study questionnaires
Who cannot join
- Patient has a history or presence of a major psychiatric disorder
- Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- Patient has a history of seizures or is at high risk of developing seizures
- Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
- Patient has diabetes mellitus as defined by medical history
About this study
Official title: A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
- Conditions
- Obesity
- Being tested
- taranabant, Comparator: placebo
- Keywords
- Weight loss, Weight regain, Weight maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taranabantDrug
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
Comparator: placeboDrug
Placebo capsules once daily. Treatment for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Arm 1: MK0364 Pbo capsules once daily Receives: Drug: Comparator: placebo |
| 2 | Experimental | Arm 2: MK0364 0.5 mg capsule once daily Receives: Drug: taranabant |
| 3 | Experimental | Arm 3: MK0364 1 mg capsule once daily Receives: Drug: taranabant |
| 4 | Experimental | Arm 4: MK0364 2 mg capsule once daily Receives: Drug: taranabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight at 52 weeks, safety and tolerability.
Measured: 52 weeks
Secondary outcomes (1)
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionFeb 2008
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420589
- Sponsor's protocol ID
- 0364-012
- Other IDs
- 2006_512
- Status last verified
- Feb 2015
- First submitted
- 5 Jan 2007
- Last updated
- 5 Feb 2015
- Results posted
- No
Publications
Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.
PubMed 20379151
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension
- ClinicalTrials.gov ID
- NCT00420589
- Acronym / sponsor ID
- 0364-012
- Conditions
- Obesity
- Keywords
- Weight loss, Weight regain, Weight maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The overall profile does not support development for obesity
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Jan 2007 (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.
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: placeboArm 1: MK0364 Pbo capsules once daily |
| 2 | Experimental | Drug: taranabantArm 2: MK0364 0.5 mg capsule once daily |
| 3 | Experimental | Drug: taranabantArm 3: MK0364 1 mg capsule once daily |
| 4 | Experimental | Drug: taranabantArm 4: MK0364 2 mg capsule once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- Patient is male or female >=18 and <= 65 years of age
- Patient understands the study procedures and alternative treatments available
- Patient is able to read, understand and complete study questionnaires
Key exclusion criteria (5 listed)
- Patient has a history or presence of a major psychiatric disorder
- Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- Patient has a history of seizures or is at high risk of developing seizures
- Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
- Patient has diabetes mellitus as defined by medical history
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 |
|---|---|---|
| taranabanttaranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks. | Drug | 2, 3, 4 |
| Comparator: placeboPlacebo capsules once daily. Treatment for 52 weeks | Drug | 1 |
Primary outcome
Body weight at 52 weeks, safety and tolerability.
Time frame: 52 weeks
1 secondary outcome
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
Time frame: 52 weeks
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 5 Feb 2015.
- Results publication: PubMed 20379151Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.
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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 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 4 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 5 Feb 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?
Body weight at 52 weeks, safety and tolerability. (time frame: 52 weeks). 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 NCT00420589, which also lists 1 linked publication.
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 5 Feb 2015.