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Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)

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)

NCT00666016•Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•* 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
+10 more criteria

Exclusion Criteria

•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.
•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.
+7 more criteria

Locations (5)

CHU AMIENS, Service d'Hépato-Gastroentérologie

Amiens, France

Centre Hospitalier de Hyères, Hôpital de Jour, Service d'Hépato-Gastro-Entérologie

Hyères, France

Hôpital Saint Joseph, Service d'Hépato-Gastro-Entérologie

Marseille, France

Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière

Nice, France

Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital

Paris, France

Key Dates

Start Date

April 15, 2008

Primary Completion Date

February 5, 2009

Completion Date

February 5, 2009

Last Updated

December 18, 2025

Enrollment

ACTUAL participants

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Interventions

TRO19622

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Inclusion Criteria

Exclusion Criteria

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)

A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

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