Combined Active Treatment in Type 2 Diabetes with NASH

Lead sponsor

German Diabetes Center

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

192

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Eligibility highlights

•HbA1c ≤9.5%

Primary endpoint

•MASH resolution, no fibrosis worsening

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04639414

Org study IDCombat_T2_NASH_002

Secondary ID2019-001987-31

Timeline

Milestones

Study first posted2020-11-20actual

Study start2021-03-26actual

Last update posted2024-10-10actual

Primary completion2025-01-31estimated

Study completion2025-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Who can enroll

Minimum age25 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of T2D and NASH with fibrosis stage F1-F3

•Age between 25 and 75 years

•HbA1c ≤ 9.5%

•obtained written informed consent

Exclusion criteria

•Contraindications on liver biopsy

•Evidence of cirrhosis on liver biopsy

•Liver disease of other etiology including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology

•History of ketoacidosis

•Alcohol consumption >30 g/d for males and >20 g/d for females

•Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment

•Medications that may induce steatosis:tamoxifen, raloxifene, oral glucocorticoids or chloroquine

•Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.