Non-Alcoholic Steatohepatitis (NASH)Phase 2NCT00666016
Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)
A Phase 2 study testing TRO19622 in people with Non-Alcoholic Steatohepatitis (NASH), run by Hoffmann-La Roche at 5 sites in France.
Trial summary
The purpose of this study is to assess the safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Steatohepatitis (NASH)
- What is being tested?
- TRO19622
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Apr 2008to 5 Feb 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects older than 18 years.
- Persistent ALT elevation (> 2 times the ULN of the local laboratory of the investigating site) over 6 months prior to entry into study.
- No more than one ALT value within the normal range in the past year.
- Patients must have had an ALT measurement at least once every 6 months within the year before inclusion.
- Histologically confirmed diagnosis of steatohepatitis on biopsy within 2 years prior to entry into protocol.
- Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
Show all 20Show fewer
- Hemoglobin > 11 gm/dL for females and > 12 gm/dL for males
- White blood cell (WBC) > 2.5 K/UL
- Neutrophil count > 1.5 K/UL
- Platelets > 100 K/UL
- Total bilirubin < 35 µmol/L)
- Albumin > 36 g/L
- TP > 80% .
- Serum creatinine within normal limits
- No other cause of chronic liver disease (autoimmune,primary biliary cirrhosis, HBV, Wilson, alpha-1-antitrypsin deficit, hemochromatosis etc\dots )
- If applicable, have a stable diabetes, defined as HbA1c < 9% and fasting glycemia < 10 mmol/L,no changes in medication in the previous 6 months, and no new symptoms associated with diabetes in the previous 3 months.
- If applicable have a stable metabolic condition (diagnosis made at least 6 months before inclusion), without major weight or laboratory tests changes.
- Negative pregnancy test or post menopausal.
- Have an electrocardiogram (ECG) without any clinically significant abnormality.
- Subjects must be willing to give written informed consent.
Who cannot join
- Evidence of another form of liver disease.
- History of excess alcohol ingestion: daily alcohol consumption >30 g/day (3 drinks per day) for males and >20 g/day (2 drinks/day) for females.
- Unstable metabolic condition: Weight change > +/- 10% in the previous year, diabetes with poor glycemic control (HbA1c >9%),introduction of an antidiabetic or of an anti-obesity drug in the past 6 months prior to screening.
- History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids,high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
- Significant systemic or major illnesses other than liver disease,including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease,malignancy that, in the opinion of the investigator would preclude treatment with TRO19622 and/or adequate follow up.
- HIV infection.
Show all 17Show fewer
- Active substance abuse, such as inhaled or injection drugs within the previous year.
- Pregnancy or inability to practice adequate contraception in women of child-bearing potential.
- Active malignancy except cutaneous basocellular carcinoma.
- Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.
- Body mass index (BMI) >40 kg/m2 (obesity Grade III).
- Type 1 diabetes or Insulin-treated type 2 diabetes.
- Hemostasis disorders or current treatment with anticoagulants.
- History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease, including myocardial infarction, except patients with only well controlled hypertension.
- Participation in any other investigational drug or therapy study within the previous 3 months.
- Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
- Medications that could interfere with TRO19622 absorption
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU AMIENS, Service d'Hépato-Gastroentérologie
Amiens, 80054
Centre Hospitalier de Hyères, Hôpital de Jour, Service d'Hépato-Gastro-Entérologie
Hyères, 83407
Hôpital Saint Joseph, Service d'Hépato-Gastro-Entérologie
Marseille, 13285
Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière
Nice, 06200
Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital
Paris, 75651
About this study
Official title: Double-Blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients With Non-Alcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH).
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- TRO19622, Placebo
- Keywords
- non alcoholic steatohepatitis nash hepatoprotective hepatoprotection ALT AST new drug candidate interventional study TRO19622 Trophos cholest-4-en-3-one oxime
- 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.
TRO19622Drug
Also called Olesoxime
TRO19622 500 mg once a day before noon meal during 6 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TRO19622 | Experimental | TRO19622 500 mg Receives: Drug: TRO19622 |
| 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.
Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gender, subject and time and a non parametric test (Conover-Salsburg).
Measured: Mean change in ALT at V1 (Day15) and V2 (Day 30)
Secondary outcomes (1)
Sustained reduction in ALT to either 50% of baseline or value < or equal to ULN. Sustained reduction serum AST and GGT.Clinical and laboratory safety.
Measured: V1 (Day 15), V2 (Day 30) and V3 (Day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study start15 Apr 2008
- Primary completion5 Feb 2009
- Study completion5 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trophos
- Responsible party
- Sponsor
- Investigators
- Vlad Ratziu, MD, Principal investigator, GH PITIE-SALPETRIERE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666016
- Sponsor's protocol ID
- WN29850
- Other IDs
- TRO19622 CL E Q 1159-1
- Status last verified
- Dec 2025
- First submitted
- 22 Apr 2008
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients With Non-Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT00666016
- Acronym / sponsor ID
- WN29850
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Keywords
- non alcoholic steatohepatitis nash hepatoprotective hepatoprotection ALT AST new drug candidate interventional study TRO19622 Trophos cholest-4-en-3-one oxime
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trophos
- Study start
- 15 Apr 2008 (actual)
- Primary completion
- 5 Feb 2009 (actual)
- Study completion
- 5 Feb 2009 (actual)
- First posted
- 24 Apr 2008 (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 safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRO19622 | Experimental | Drug: TRO19622TRO19622 500 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult subjects older than 18 years.
- Persistent ALT elevation (> 2 times the ULN of the local laboratory of the investigating site) over 6 months prior to entry into study.
- Histologically confirmed diagnosis of steatohepatitis on biopsy within 2 years prior to entry into protocol.
- Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
- No other cause of chronic liver disease (autoimmune,primary biliary cirrhosis, HBV, Wilson, alpha-1-antitrypsin deficit, hemochromatosis etc\dots )
Key exclusion criteria (17 listed)
- Evidence of another form of liver disease.
- History of excess alcohol ingestion: daily alcohol consumption >30 g/day (3 drinks per day) for males and >20 g/day (2 drinks/day) for females.
- Unstable metabolic condition: Weight change > +/- 10% in the previous year, diabetes with poor glycemic control (HbA1c >9%),introduction of an antidiabetic or of an anti-obesity drug in the past 6 months prior to screening.
- History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids,high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
- Significant systemic or major illnesses other than liver disease,including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease,malignancy that, in the opinion of the investigator would preclude treatment with TRO19622 and/or adequate follow up.
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 |
|---|---|---|
| TRO19622Also: OlesoximeTRO19622 500 mg once a day before noon meal during 6 weeks | Drug | TRO19622 |
| Placebo | Drug | Placebo |
Primary outcome
Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gender, subject and time and a non parametric test (Conover-Salsburg).
Time frame: Mean change in ALT at V1 (Day15) and V2 (Day 30)
1 secondary outcome
Sustained reduction in ALT to either 50% of baseline or value < or equal to ULN. Sustained reduction serum AST and GGT.Clinical and laboratory safety.
Time frame: V1 (Day 15), V2 (Day 30) and V3 (Day 60)
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 18 Dec 2025.
Related trials for Non-Alcoholic Steatohepatitis (NASH)
Active, not recruitingPhase 2
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
NASH
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
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.
Vlad Ratziu, MD principal investigator
GH PITIE-SALPETRIERE
5 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 TRO19622 in people with Non-Alcoholic Steatohepatitis (NASH), run by Hoffmann-La Roche at 5 sites in France.
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 20 inclusion and 17 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gender, subject and time and a non parametric test (Conover-Salsburg). (time frame: Mean change in ALT at V1 (Day15) and V2 (Day 30)). 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 Dec 2025.