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

NCT00666016 | Completed Phase 2

• 2 other identifiers: WN29850TRO19622 CL E Q 1159-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief 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).

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  V1 (Day 15), V2 (Day 30) and V3 (Day 60)

Study Arms (2)

TRO19622

EXPERIMENTAL

TRO19622 500 mg

Drug: TRO19622

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRO19622 DRUG

TRO19622 500 mg once a day before noon meal during 6 weeks

Also known as: Olesoxime

TRO19622

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Trophos: collaborator
• Hoffmann-La Roche: lead

Study Sites (5)

CHU AMIENS, Service d'Hépato-Gastroentérologie

Amiens, 80054, France

Location

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

Hyères, 83407, France

Location

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

Marseille, 13285, France

Location

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

Nice, 06200, France

Location

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

Paris, 75651, France

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

olesoxime

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vlad Ratziu, MD

  GH PITIE-SALPETRIERE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: April 15, 2008
• Primary Completion: February 5, 2009
• Study Completion: February 5, 2009
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

FR (5)