DyslipidemiaPhase 2NCT00847197
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
A Phase 2 study testing MK1903 in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- MK1903
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is not on a statin or other lipid-modifying therapy
- Low or moderate risk participant
- Male participants, and female participants not of reproductive potential
Who cannot join
- Female participant of reproductive potential
- Participant is pregnant, breastfeeding, or expecting to conceive during the study
- Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
- Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
- Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
- Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
Show all 24Show fewer
- Participant is currently experiencing menopausal hot flashes
- Participant currently engages in vigorous exercise or an aggressive diet regimen
- Participant is at high risk for heart conditions
- Participant has Type 1 or Type 2 diabetes mellitus
- Participant has poorly controlled cardiac arrhythmias
- Participant has a history of stroke or other hemorrhage
- Participant has poorly controlled high blood pressure
- Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
- Participant has a disease of the kidney or liver
- Participant has an ulcer within 3 months of screening
- Participant is Human Immunodeficiency Virus (HIV) positive
- Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
- Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
- Participant has taken an anti-obesity medication within 3 months of screening
- Participant is taking coumarins
- Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
- Participant is taking more than 100 mg aspirin per day
- Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
- Conditions
- Dyslipidemia
- Being tested
- MK1903, Comparator: Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK1903Drug
Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Comparator: PlaceboDrug
Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK1903 Receives: Drug: MK1903 |
| 2 | Placebo comparator | Placebo to MK1903 Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Measured: Baseline and Week 4
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Measured: Baseline and Week 4
Secondary outcomes (1)
Percent Change From Baseline in Triglycerides (mg/dL)
Measured: Baseline and 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiaStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 191 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
- NCT00847197
- Sponsor's protocol ID
- 1903-004
- Other IDs
- 2009_542
- Status last verified
- Nov 2015
- First submitted
- 18 Feb 2009
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT00847197
- Acronym / sponsor ID
- 1903-004
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 22 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK1903MK1903 |
| 2 | Placebo comparator | Drug: Comparator: PlaceboPlacebo to MK1903 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is not on a statin or other lipid-modifying therapy
- Low or moderate risk participant
- Male participants, and female participants not of reproductive potential
Key exclusion criteria (24 listed)
- Female participant of reproductive potential
- Participant is pregnant, breastfeeding, or expecting to conceive during the study
- Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
- Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
- Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
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 |
|---|---|---|
| MK1903Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period. | Drug | 1 |
| Comparator: PlaceboThree 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period. | Drug | 2 |
Primary outcome
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Time frame: Baseline and Week 4
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Time frame: Baseline and Week 4
1 secondary outcome
Percent Change From Baseline in Triglycerides (mg/dL)
Time frame: Baseline and 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Active, not recruitingObservational study
Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
Dyslipidemia, Obesity & Overweight
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
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 MK1903 in people with Dyslipidemia, 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 24 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 21 Dec 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 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?
Yes. Results are posted in the registry (first posted 22 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.