A study to evaluate the safety and efficacy of cotadutide given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis

JRCT ID: jRCT2051220031

Registered date:25/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 02/11/2022
• Target sample size: 8
• Countries of recruitment: Austria,Japan,France,Japan,Greece,Japan,Italy,Japan,Malaysia,Japan,New Zealand,Japan,South Africa,Japan,Korea,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan,Thailand,Japan
• Study type: Interventional
• Intervention(s): Cotadutide is administered subcutaneously once daily in increasing doses from 50ug to 300ug or 600ug.

Outcome(s)

Primary Outcome

Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments, and ECG.
Incidence of ADAs to cotadutide and titer during treatment and follow-up

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. Provision of informed consent

2. Males and female participants more or 18 to less or equal to 75 years of age (inclusive) at the time of signing the informed consent.

3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed less than or equal to 180 days from randomization and fulfilling all of the following histological criteria:

a. NAS (Non-alcoholic Fatty Liver Disease Activity Score) more or equal to 4 with a score of less or equal to 1 for each component: steatosis, lobular inflammation, and ballooning

b. Presence of fibrosis stage F2 or F3

4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.

Exclude criteria

1. Chronic liver disease of other etiologies.

2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).

3. Clinically significant cardiovascular or cerebrovascular disease within90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening

4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.

5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.

6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator

8. Severely uncontrolled hypertension defined as SBP more or equal to 180 mmHg or DBP more or equal to 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization

9. Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05364931