NASHPhase 2NCT02923154
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
A Phase 2 study testing MT-3995 in people with NASH, run by Tanabe Pharma Corporation at 2 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- NASH
- What is being tested?
- MT-3995
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2016to Apr 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with NASH before randomization
- Subjects who conducts diet or exercise therapy at the beginning of run in period.
- Subjects who has given full and adequate information of the protocol and with written informed consent
Who cannot join
- Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
- Subjects with alcohol dependence or previously diagnosed with alcohol dependence
- Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
- Presence, history, or family history of long QT syndrome or Torsades de Pointes
- Subjects with heart failure (New York Heart Association Class III-IV)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.
- Conditions
- NASH
- Being tested
- MT-3995, Placebo
- Keywords
- NASH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3995Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-3995 | Experimental | Not described Receives: Drug: MT-3995 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in ALT
Measured: 24 weeks
Secondary outcomes (2)
Change from baseline in ALT
Measured: 24 weeks
Adverse events
Measured: From baseline to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923154
- Sponsor's protocol ID
- MT-3995-J07
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
- ClinicalTrials.gov ID
- NCT02923154
- Acronym / sponsor ID
- MT-3995-J07
- Conditions
- NASH
- Keywords
- NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 4 Oct 2016 (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 of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-3995 | Experimental | Drug: MT-3995 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects diagnosed with NASH before randomization
- Subjects who conducts diet or exercise therapy at the beginning of run in period.
- Subjects who has given full and adequate information of the protocol and with written informed consent
Key exclusion criteria (5 listed)
- Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
- Subjects with alcohol dependence or previously diagnosed with alcohol dependence
- Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
- Presence, history, or family history of long QT syndrome or Torsades de Pointes
- Subjects with heart failure (New York Heart Association Class III-IV)
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 |
|---|---|---|
| MT-3995 | Drug | MT-3995 |
| Placebo | Drug | Placebo |
Primary outcome
Percent change from baseline in ALT
Time frame: 24 weeks
2 secondary outcomes
Change from baseline in ALT
Time frame: 24 weeks
Adverse events
Time frame: From baseline to 72 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 6 Sep 2019.
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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.
General Manager study director
Tanabe Pharma Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-3995 in people with NASH, run by Tanabe Pharma Corporation at 2 sites in Japan.
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 5 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Percent change from baseline in ALT (time frame: 24 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 6 Sep 2019.