ObesityPhase 3NCT00131404
A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)
A Phase 3 study testing taranabant in people with Obesity, run by Merck Sharp & Dohme LLC.
Trial summary
A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- Sep 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
- Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea
Who cannot join
- Patients with serious or unstable current or past medical conditions
About this study
Official title: A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension
A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.
- Conditions
- Obesity
- Being tested
- 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.
taranabantDrug
Also called MK0364
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Comparator: PlaceboDrug
Placebo capsule once daily. 52 week treatment period.
| 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 Phase B will remain in the same arm they were assigned to during Phase 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 2 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily. Receives: Drug: taranabant |
| Phase A/B: Arm 3 | Experimental | Phase A: Arm 3: MK0364 4 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3:
MK0364 4 mg capsule once daily. Receives: Drug: taranabant |
| Phase A/B: Arm 4 | Experimental | Phase A: Arm 4: MK0364 6 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4:
MK0364 6 mg capsule once daily. Receives: Drug: taranabant |
| Phase A/B: Arm 5 | Experimental | Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily. Receives: Drug: taranabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreases body weight; safety and tolerability
Measured: 156 Weeks
Secondary outcomes (1)
Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity
Measured: 156 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2007
- 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,400 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
- NCT00131404
- Sponsor's protocol ID
- 0364-015
- Other IDs
- 2005_031
- Status last verified
- Feb 2015
- First submitted
- 16 Aug 2005
- Last updated
- 5 Feb 2015
- Results posted
- No
Publications
Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.
PubMed 20157323
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 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension
- ClinicalTrials.gov ID
- NCT00131404
- Acronym / sponsor ID
- 0364-015
- 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
- Sep 2005
- Primary completion
- Feb 2007 (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 study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| 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 Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily. |
| Phase A/B: Arm 2 | Experimental | Drug: taranabantPhase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily. |
| Phase A/B: Arm 3 | Experimental | Drug: taranabantPhase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily. |
| Phase A/B: Arm 4 | Experimental | Drug: taranabantPhase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily. |
| Phase A/B: Arm 5 | Experimental | Drug: taranabantPhase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: 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)
- Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea
Key exclusion criteria (1 listed)
- Patients with serious or unstable current or past medical conditions
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 |
|---|---|---|
| taranabantAlso: MK0364taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 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 |
| Comparator: PlaceboPlacebo capsule once daily. 52 week treatment period. | Drug | Phase A/B: Arm 1 |
Primary outcome
Decreases body weight; safety and tolerability
Time frame: 156 Weeks
1 secondary outcome
Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity
Time frame: 156 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 20157323Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.
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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 1 inclusion and 1 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?
Decreases body weight; safety and tolerability (time frame: 156 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 NCT00131404, 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.