ObesityPhase 2NCT00482638
Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)
A Phase 2 study testing MK0493 in people with Obesity, run by Merck Sharp & Dohme LLC.
Trial summary
To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- MK0493
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 12 May 2004to 29 Oct 2004
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 21 and 65 years
- Patient is able to read and understand and complete study questionnaires
- Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period
Who cannot join
- Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
- Patient is HIV positive as determined by medical history
- Patient has undergone surgical treatment for obesity
- Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
- Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
- Patient is currently a heavy consumer of alcohol (>2 drinks per day or >14 drinks per week [1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse
About this study
To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.
- Conditions
- Obesity
- Being tested
- MK0493
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0493Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study start12 May 2004
- Primary completion29 Oct 2004
- Study completion29 Oct 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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
- NCT00482638
- Sponsor's protocol ID
- 0493-008
- Other IDs
- 2007_571
- Status last verified
- Nov 2019
- First submitted
- 1 Jun 2007
- Last updated
- 14 Nov 2019
- Results posted
- No
Publications
Krishna R, Gumbiner B, Stevens C, Musser B, Mallick M, Suryawanshi S, Maganti L, Zhu H, Han TH, Scherer L, Simpson B, Cosgrove D, Gottesdiener K, Amatruda J, Rolls BJ, Blundell J, Bray GA, Fujioka K, Heymsfield SB, Wagner JA, Herman GA. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. Clin Pharmacol Ther. 2009 Dec;86(6):659-66. doi: 10.1038/clpt.2009.167. Epub 2009 Sep 9.
PubMed 19741604
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)
- ClinicalTrials.gov ID
- NCT00482638
- Acronym / sponsor ID
- 0493-008
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 May 2004 (actual)
- Primary completion
- 29 Oct 2004 (actual)
- Study completion
- 29 Oct 2004 (actual)
- First posted
- 5 Jun 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 assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is between 21 and 65 years
- Patient is able to read and understand and complete study questionnaires
- Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period
Key exclusion criteria (6 listed)
- Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
- Patient is HIV positive as determined by medical history
- Patient has undergone surgical treatment for obesity
- Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
- Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
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 |
|---|---|---|
| MK0493 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Results publication: PubMed 19741604Krishna R, Gumbiner B, Stevens C, Musser B, Mallick M, Suryawanshi S, Maganti L, Zhu H, Han TH, Scherer L, Simpson B, Cosgrove D, Gottesdiener K, Amatruda J, Rolls BJ, Blundell J, Bray GA, Fujioka K, Heymsfield SB, Wagner JA, Herman GA. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. Clin Pharmacol Ther. 2009 Dec;86(6):659-66. doi: 10.1038/clpt.2009.167. Epub 2009 Sep 9.
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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 2 study testing MK0493 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Nov 2019. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482638, 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 14 Nov 2019.