HypertriglyceridemiaPhase 2NCT00562575
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides
A Phase 2 study testing SLx-4090 in people with Hypertriglyceridemia, run by Response Pharmaceuticals at 1 site in Germany.
Trial summary
The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- SLx-4090
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Feb 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with high triglyceride levels
- Male or female subjects between age 18 and 65 years, inclusive
Who cannot join
- History of drug abuse
- Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
- Blood donation of more than 500ml blood in the previous 3 months
- Any confirmed significant allergic reaction against any drug or multiple allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics Profile of SLx-4090 Over 14 Days Dosing in Subjects With High Triglyceride Values
The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.
Read the detailed description
- Serum triglycerides
- Serum lipids and lipoproteins
- Safety and tolerability
- Conditions
- Hypertriglyceridemia
- Being tested
- SLx-4090, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLx-4090Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SLx-4090 Receives: Drug: SLx-4090 |
| 2 | Placebo comparator | Matching Placebo Dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum triglycerides
Measured: 14 days
Secondary outcomes (1)
Adverse events and vital signs
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Anderson, MD, Principal investigator, FOCUS clinical Drug Development GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562575
- Sponsor's protocol ID
- SLx-4090-07-03
- Status last verified
- Apr 2023
- First submitted
- 20 Nov 2007
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics Profile of SLx-4090 Over 14 Days Dosing in Subjects With High Triglyceride Values
- ClinicalTrials.gov ID
- NCT00562575
- Acronym / sponsor ID
- SLx-4090-07-03
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Response PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Nov 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.
The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.
Detailed description
- Serum triglycerides
- Serum lipids and lipoproteins
- Safety and tolerability
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: SLx-4090SLx-4090 |
| 2 | Placebo comparator | Drug: PlaceboMatching Placebo Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects with high triglyceride levels
- Male or female subjects between age 18 and 65 years, inclusive
Key exclusion criteria (4 listed)
- History of drug abuse
- Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
- Blood donation of more than 500ml blood in the previous 3 months
- Any confirmed significant allergic reaction against any drug or multiple allergies
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 |
|---|---|---|
| SLx-4090 | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Serum triglycerides
Time frame: 14 days
1 secondary outcome
Adverse events and vital signs
Time frame: 14 days
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 18 Nov 2023.
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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.
Grit Anderson, MD principal investigator
FOCUS clinical Drug Development GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLx-4090 in people with Hypertriglyceridemia, run by Response Pharmaceuticals at 1 site in Germany.
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 2 inclusion and 4 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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.
What does the primary outcome measure?
Serum triglycerides (time frame: 14 days). 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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.