Nonalcoholic Fatty Liver DiseasePhase 2NCT02029586
Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis
A Phase 2 study testing MB12066 200mg in people with Nonalcoholic Fatty Liver Disease, run by Yungjin Pharm. Co., Ltd. at 10 sites in South Korea.
Trial summary
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- MB12066 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jan 2013to Nov 2014
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)
Who cannot join
- Alcohol consumption > 20g/day
- Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%)
- Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.)
- ALT, AST > 5X the upper limit of normal
- Serum creatinine ≥ 2mg/dl
- Fibrosis score ≥ 3 according to the NASH CRN fibrosis staging system
Show all 11Show fewer
- NQO1 T/T type
- Weight loss of more than 5kg within 6 months
- Bariatric surgery within 6 months
- Known alcohol or any other drug abuse in the last five years
- Insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Keimyung University Donsan Medical Center
Daegu, Dalseong-ro Jung-gu, 700-712
Kyungpook National University Hospital
Daegu, Dongdeok-ro Jung-gu, 700-721
Seoul St. Mary's Hospital
Seoul, Banpo-daero Seocho-gu, 137-701
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, 110-744
Chung-ang University Hospital
Seoul, Heukseok-dong Dongjak-gu, 156-755
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736
Boramae Hospital
Seoul, Sindaebang-dong Dongjak-gu, 156-707
Hanyang University Medical Center
Seoul, Wangsimni-ro Seongdong-gu, 133-792
Severance Hospital
Seoul, Yonsei-ro Seodaemun-gu, 120-752
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Cheonbo-ro Gyeonggi-do, 480-710
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) Except Cirrhosis
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- MB12066 200mg, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB12066 200mgDrug
oral administration, 100mg bid
PlaceboDrug
oral administration, 100mg bid
| Study group | Role | What they receive |
|---|---|---|
| MB12066 | Experimental | Not described Receives: Drug: MB12066 200mg |
| 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.
Change in hepatic steatosis(%)
The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
Measured: baseline, 12 weeks
Secondary outcomes (6)
Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
Measured: baseline, 12 weeks
Change in fibrosis score
Measured: baseline, 12 weeks
Change in steatosis score
Measured: baseline, 12weeks
Change in lobular inflammation score
Measured: baseline, 12weeks
Change in ballooning score
Measured: baseline, 12weeks
Change in lipid profile
Measured: baseline, 4weeks, 8weeks, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yungjin Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029586
- Sponsor's protocol ID
- MB12066_201
- Status last verified
- Dec 2017
- First submitted
- 6 Jan 2014
- Last updated
- 21 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) Except Cirrhosis
- ClinicalTrials.gov ID
- NCT02029586
- Acronym / sponsor ID
- MB12066_201
- Conditions
- Nonalcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Jan 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.
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.
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 |
|---|---|---|
| MB12066 | Experimental | Drug: MB12066 200mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)
Key exclusion criteria (11 listed)
- Alcohol consumption > 20g/day
- Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%)
- Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.)
- ALT, AST > 5X the upper limit of normal
- Serum creatinine ≥ 2mg/dl
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 |
|---|---|---|
| MB12066 200mgoral administration, 100mg bid | Drug | MB12066 |
| Placebooral administration, 100mg bid | Drug | Placebo |
Primary outcome
Change in hepatic steatosis(%)
Time frame: baseline, 12 weeks
The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
6 secondary outcomes
Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
Time frame: baseline, 12 weeks
Change in fibrosis score
Time frame: baseline, 12 weeks
Change in steatosis score
Time frame: baseline, 12weeks
Change in lobular inflammation score
Time frame: baseline, 12weeks
Change in ballooning score
Time frame: baseline, 12weeks
Change in lipid profile
Time frame: baseline, 4weeks, 8weeks, 12weeks
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
10 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 MB12066 200mg in people with Nonalcoholic Fatty Liver Disease, run by Yungjin Pharm. Co., Ltd. at 10 sites in South Korea.
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 11 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: stopped early, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Change in hepatic steatosis(%) (time frame: baseline, 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 21 Dec 2017.