NL-OMON47918
Completed
Phase 2
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. - SEMA-NASH
ovo Nordisk0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-alcoholic steatohepatitis
- Sponsor
- ovo Nordisk
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Informed consent obtained before any trial\-related activities.
- •\* Male or female, aged 18\-75 years (both inclusive)
- •\* Histologic evidence of NASH based on central pathologist evaluation
- •\* A histological NAS \* 4 with a score of 1 or more in each sub\-component of the score based on central pathologist evaluation.
- •\* NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
Exclusion Criteria
- •\* Known or suspected abuse of alcohol, alcohol dependence or narcotics.
- •\* Diagnosis of type 1 diabetes according to medical records.
- •\* HbA1c \> 10% at screening.
- •\* History or presence of pancreatitis (acute or chronic).
- •\* Calcitonin \* 50 ng/L at screening.
- •\* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •\* Body Mass Index (BMI) \* 25\.0 kg/m2 at the screening visit.
- •\* Female who is pregnant, breast\-feeding or intends to become pregnant.
Outcomes
Primary Outcomes
Not specified
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