Non-alcoholic Fatty Liver Disease (NAFLD)Phase 2NCT01811472
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
A Phase 2 study testing LCQ908 in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Novartis Pharmaceuticals at 11 sites in United States.
Trial summary
The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- LCQ908
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2013to Sep 2014
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of liver steatosis during the preceding 24 months
- History of fasting TGs > 200 mg/dL (confirmed at screening).
- Liver fat ≥ 10% as determined by the central MRI laboratory.
- Subjects on the following medications can be included if these medications are medically necessary, cannot be stopped and the investigator feels their dose will remain stable for the duration of the double-blind treatment period:
- Stable dose of anti-diabetic medications (metformin and/or sulfonylureas) for at least 8 weeks prior to screening.
- Stable doses of beta-blockers and thiazide diuretics for at least 8 weeks prior to screening.
- Stable doses of fibrates, statins, niacin, ezetimibe for at least 8 weeks prior to screening.
- Stable dose of vitamin E in patients taking >200 IU/day for at least 6 months prior to screening.
Who cannot join
- Treatment with omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day within 8 weeks of screening.
- Treatment with antiretrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within 8 weeks of screening.
- ALT or AST > 250 IU/L at the time of screening.
- History/current evidence of heavy alcohol use or alcoholism (> 21 drinks per week in men and > 14 drinks per week in women) over a 2-year period prior to screening.
- Presence of chronic liver disease, such as chronic hepatitis B and/or C, alcoholic liver disease, hemochromatosis, Wilson's disease, known cirrhosis.
- Platelet count <150,000 at screening.
- BMI >45 Kg/m2.
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Novartis Investigative Site
Gainesville, Florida, 32610-0277
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Louisville, Kentucky, 40213
Novartis Investigative Site
Miami, Florida, 33126
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Plano, Texas, 75093
Novartis Investigative Site
Richmond, Virginia, 23298
Novartis Investigative Site
San Diego, California, 92114
Novartis Investigative Site
Tamarac, Florida, 33319
Novartis Investigative Site
Tupelo, Mississippi, 38801
About this study
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group, 24-week Pilot Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in Patients With Non-alcoholic Fatty Liver Disease
The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).
- Being tested
- LCQ908, placebo
- Keywords
- Multi-center,, randomized,, double-blind,, NAFLD,, elevated triglycerides
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCQ908Drug
Also called pradigastat
LCQ908 5 mg, 10 mg, 20 mg tablets
placeboDrug
Matching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Receives: Drug: placebo |
| pradigastat (LCQ908) 5mg/10mg | Experimental | Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Receives: Drug: LCQ908 |
| pradigastat (LCQ908) 10mg/20mg | Experimental | Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Receives: Drug: LCQ908 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24
Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
Measured: From baseline to week 24
Secondary outcomes (12)
Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12
Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
Measured: From baseline to week 12
Percentage of Responders at Week 12
The response criteria are defined as:
- A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.
Measured: At week 12
Percentage of Responders at Week 24
The response criteria are defined as:
- A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.
Measured: From baseline to week 24
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6
Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.
Measured: From Baseline to week 6
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12
Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.
Measured: From Baseline to week 12
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24
Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.
Measured: From Baseline to week 24
Percentage of Patients With Normalized Liver Enzymes
Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.
Measured: Baseline, week 6, week 12 and week 24
Percent Change From Baseline in Fasting Triglycerides
Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.
Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization).
Measured: Baseline, 6, 12 and 24 weeks
Post-prandial Peak Triglycerides Over 0 - 8 Hours
Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.
Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization).
Measured: Baseline, 6 and 24 weeks
Change From Baseline in Body Weight
Measured: Baseline, 12 and 24 weeks
Change From Baseline in Waist Circumference
Measured: Baseline, 12 and 24 weeks
Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
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 Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811472
- Sponsor's protocol ID
- CLCQ908A2216
- Other IDs
- 2013-000049-38
- Status last verified
- Jan 2016
- First submitted
- 12 Mar 2013
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group, 24-week Pilot Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01811472
- Acronym / sponsor ID
- CLCQ908A2216
- Keywords
- Multi-center,, randomized,, double-blind,, NAFLD,, elevated triglycerides
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 4 Feb 2016
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 was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPatients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. |
| pradigastat (LCQ908) 5mg/10mg | Experimental | Drug: LCQ908Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. |
| pradigastat (LCQ908) 10mg/20mg | Experimental | Drug: LCQ908Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of liver steatosis during the preceding 24 months
- History of fasting TGs > 200 mg/dL (confirmed at screening).
- Liver fat ≥ 10% as determined by the central MRI laboratory.
- Subjects on the following medications can be included if these medications are medically necessary, cannot be stopped and the investigator feels their dose will remain stable for the duration of the double-blind treatment period:
Key exclusion criteria (8 listed)
- Treatment with omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day within 8 weeks of screening.
- Treatment with antiretrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within 8 weeks of screening.
- ALT or AST > 250 IU/L at the time of screening.
- History/current evidence of heavy alcohol use or alcoholism (> 21 drinks per week in men and > 14 drinks per week in women) over a 2-year period prior to screening.
- Presence of chronic liver disease, such as chronic hepatitis B and/or C, alcoholic liver disease, hemochromatosis, Wilson's disease, known cirrhosis.
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 |
|---|---|---|
| LCQ908Also: pradigastatLCQ908 5 mg, 10 mg, 20 mg tablets | Drug | pradigastat (LCQ908) 10mg/20mg, pradigastat (LCQ908) 5mg/10mg |
| placeboMatching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets. | Drug | Placebo |
Primary outcome
Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24
Time frame: From baseline to week 24
Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
12 secondary outcomes
Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12
Time frame: From baseline to week 12
Percentage of Responders at Week 12
Time frame: At week 12
Percentage of Responders at Week 24
Time frame: From baseline to week 24
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6
Time frame: From Baseline to week 6
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12
Time frame: From Baseline to week 12
Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24
Time frame: From Baseline to week 24
Percentage of Patients With Normalized Liver Enzymes
Time frame: Baseline, week 6, week 12 and week 24
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, 6, 12 and 24 weeks
Post-prandial Peak Triglycerides Over 0 - 8 Hours
Time frame: Baseline, 6 and 24 weeks
Change From Baseline in Body Weight
Time frame: Baseline, 12 and 24 weeks
Change From Baseline in Waist Circumference
Time frame: Baseline, 12 and 24 weeks
Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
11 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 LCQ908 in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Novartis Pharmaceuticals at 11 sites in United States.
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 8 inclusion and 8 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2016). 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?
Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 (time frame: From baseline to week 24). 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 4 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.