Fatty LiverPhase 3NCT00576667
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
A Phase 3 study testing Rimonabant in people with Fatty Liver, run by Sanofi at 24 sites in 24 countries.
Trial summary
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 24 sitesin 24 countries
- Study dates
- Jan 2008to Feb 2009
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of NASH
Who cannot join
- Excessive alcohol use
- Presence of diabetes mellitus
- Other chronic liver disease
- Previous or current hepatocellular carcinoma
- Use of medication known to cause steatosis
- Previous bariatric surgery
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- Pregnancy or breastfeeding
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
24 sites in 24 countries.
24 sites in 24 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford, Surrey
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
Read the detailed description
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
- Conditions
- Fatty Liver
- Being tested
- Rimonabant, Placebo (for Rimonabant)
- Keywords
- NASH, chronic liver disease
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
Placebo (for Rimonabant)Drug
Tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily. Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily. Receives: Drug: Placebo (for Rimonabant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Measured: Baseline to 24 months
Secondary outcomes (3)
Change from baseline in hepatic fibrosis score
Measured: Baseline to 24 months
Change from baseline in serum hyaluronate (HA)
Measured: Baseline to 24 months
Change from baseline in hepatic transaminases (AST/ALT)
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Company decision taken in light of demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576667
- Sponsor's protocol ID
- EFC10143
- Other IDs
- 2007-003013-14
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2007
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT00576667
- Acronym / sponsor ID
- EFC10143
- Conditions
- Fatty Liver
- Keywords
- NASH, chronic liver disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 165 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Dec 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 of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).
Detailed description
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
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 |
|---|---|---|
| Rimonabant | Experimental | Drug: RimonabantRimonabant 20 mg once daily. |
| Placebo | Placebo comparator | Drug: Placebo (for Rimonabant)Placebo (for Rimonabant) once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosis of NASH
Key exclusion criteria (9 listed)
- Excessive alcohol use
- Presence of diabetes mellitus
- Other chronic liver disease
- Previous or current hepatocellular carcinoma
- Use of medication known to cause steatosis
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 |
|---|---|---|
| RimonabantAlso: SR141716, AcompliaTablet, oral administration | Drug | Rimonabant |
| Placebo (for Rimonabant)Tablet, oral administration | Drug | Placebo |
Primary outcome
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Time frame: Baseline to 24 months
3 secondary outcomes
Change from baseline in hepatic fibrosis score
Time frame: Baseline to 24 months
Change from baseline in serum hyaluronate (HA)
Time frame: Baseline to 24 months
Change from baseline in hepatic transaminases (AST/ALT)
Time frame: Baseline to 24 months
Results and safety
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
ICD CSD study director
Sanofi
24 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Fatty Liver, run by Sanofi at 24 sites in 24 countries.
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 9 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Argentina, Australia, Belgium, Brazil and 19 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Company decision taken in light of demands by certain national health authorities). 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?
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) (time frame: Baseline to 24 months). 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 May 2016.