Trial · NCT06632444
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score | Baseline and at Week 52. | |
| Primary | Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH | Baseline and at Week 52. | |
| Primary | Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH | Up to 7 years. | Progression to cirrhosis is defined as histological fibrosis score CRN F4. MELD = Model for End-stage Liver Disease CSPH =clinically significant portal hypertension |
| Secondary | Key secondary endpoint part 1: Percentage change from baseline in body weight [kg] | Baseline and at Week 52. | |
| Secondary | Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%] | Baseline and at Week 52. | This endpoint is specified only for the participants with type 2 diabetes mellitus. |
| Secondary | Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score | Baseline and at Week 52. | |
| Secondary | Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE) | Baseline and at Week 52. | |
| Secondary | Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no) | Baseline and at Week 52. | |
| Secondary | Key secondary endpoint part 2: Percentage change from baseline in body weight [kg] | At baseline and at Week 114 | |
| Secondary | Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%] | At baseline and at Week 114 | This endpoint is specified only for the participants with type 2 diabetes mellitus. |
| Secondary | Key secondary endpoint part 2: Absolute change from baseline in ELF score | At baseline and at Week 114. | |
| Secondary | Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE | At baseline and at Week 114. | |
| Secondary | Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no) | At baseline and at 7 years. | |
| Secondary | Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent) | Up to 7 years. | |
| Secondary | Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE) | Up to 7 years. | |
| Secondary | Part 1: Improvement of liver fat content (LFC) | At baseline and at Week 52. | Defined as at least 30% relative reduction in LFC compared with baseline assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF). This endpoint will be reported only for a subset of participants in the MRI sub-study. |
| Secondary | Part 2: Improvement of LFC | At baseline and at Week 114. | Defined as at least 30% relative reduction in LFC compared with baseline assessed by MRI-PDFF. This endpoint will be reported only for a subset of participants in the MRI sub-study. |
| Secondary | Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF | At baseline and at Week 52. | This endpoint will be reported only for a subset of participants in the MRI sub-study. |
| Secondary | Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF | At baseline and at Week 114. | This endpoint will be reported only for a subset of participants in the MRI sub-study. |
| Secondary | Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L] | At baseline and at Week 52. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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