Elevated Lp(a)Phase 1/2NCT02241772
A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)
A Phase 1/2 study testing TA-8995 in people with Elevated Lp(a), run by Xention Ltd at 1 site in Denmark.
Trial summary
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elevated Lp(a)
- What is being tested?
- TA-8995
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Feb 2015
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels
Who cannot join
- Clinically significant medical history
- Abnormal laboratory results (other than lipid levels) or vital signs
- Receiving any other drug therapy
Trial locations and contacts
1 site in 1 country.
About this study
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.
- Conditions
- Elevated Lp(a)
- Being tested
- TA-8995, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-8995Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 10mg TA-8995 | Experimental | 10mg TA-8995 once daily Receives: Drug: TA-8995 |
| 2.5mg TA-8995 | Experimental | 2.5mg TA-8995 once daily Receives: Drug: TA-8995 |
| Placebo to TA-8995 | Placebo comparator | Placebo to TA-8995 once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
Measured: 12 weeks
Secondary outcomes (1)
Number of participants with adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Lp(a)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xention Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241772
- Sponsor's protocol ID
- TA-8995-06
- Status last verified
- Oct 2014
- First submitted
- 20 Aug 2014
- Last updated
- 16 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)
- ClinicalTrials.gov ID
- NCT02241772
- Acronym / sponsor ID
- TA-8995-06
- Conditions
- Elevated Lp(a)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Xention LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Sep 2014 (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 in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10mg TA-8995 | Experimental | Drug: TA-899510mg TA-8995 once daily |
| 2.5mg TA-8995 | Experimental | Drug: TA-89952.5mg TA-8995 once daily |
| Placebo to TA-8995 | Placebo comparator | Drug: PlaceboPlacebo to TA-8995 once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels
Key exclusion criteria (3 listed)
- Clinically significant medical history
- Abnormal laboratory results (other than lipid levels) or vital signs
- Receiving any other drug therapy
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 |
|---|---|---|
| TA-8995 | Drug | 10mg TA-8995, 2.5mg TA-8995 |
| Placebo | Drug | Placebo to TA-8995 |
Primary outcome
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
Time frame: 12 weeks
1 secondary outcome
Number of participants with adverse events
Time frame: 12 weeks
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 16 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TA-8995 in people with Elevated Lp(a), run by Xention Ltd at 1 site in Denmark.
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 3 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 16 Feb 2015. 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 Denmark. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995. (time frame: 12 weeks). 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 16 Feb 2015.