NCT06888310 (MODELS) is a NA clinical trial of extra blood sampling in NASH, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT06888310?

NCT06888310 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT06888310?

Interventions in NCT06888310: extra blood sampling.

What condition does NCT06888310 study?

NCT06888310 studies NASH, NAFLD.

Is NCT06888310 still recruiting?

NCT06888310 is currently recruiting now. Last updated 21 March 2025.

Last reviewed 2025-03-21 · How we verify

NCT06888310: MODELS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease

Recruiting now NA Last updated 21 March 2025

What this trial tests

NA trial testing extra blood sampling in NASH in 408 participants. Currently enrolling.

Timeline

6 December 2024

Primary endpoint
1 December 2026

1 March 2027

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	408
Start date	6 December 2024
Primary completion	1 December 2026
Estimated completion	1 March 2027
Sites	1 location across Italy

Drugs / interventions tested

extra blood sampling

Conditions studied

NASH — all drugs for NASH →
NAFLD — all drugs for NAFLD →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with NASH or NAFLD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-alcoholic fatty liver disease (NAFLD) is responsible for a significant proportion of liver-related deaths and healthcare costs in the United States, accounting for approximately 36% of liver-related deaths and over one billion dollars in annual healthcare expenses. \[PMID: 34863359\] A recent analysis of healthcare costs in Italy showed that out of the 9,729 NAFLD/NASH patients who were hospitalized and analyzed, the vast majority (97%) did not have advanced liver disease, while 1.3% had compensated advanced liver disease (cACLD), 3.1% had decompensated cirrhosis, 0.8% had hepatocellular carcinoma, and 0.1% underwent liver transplantation. The burden of comorbidities was high across all patient cohorts, and patients with cACLD required a greater number of inpatient services, outpatient visits, and the pharmacy fills compared to those without advanced liver disease. As disease severity increased, mean total annual costs also increased primarily due to higher inpatient services costs. In Italy, as in other EU countries, most of the healthcare costs for patients were attributed to NAFLD/NASH-related liver complications. Thus, the optimization of the non-invasive diagnosis of cACLD represents an urgent need in dysmetabolic liver disease. These advancements will play a crucial role in early detection, risk stratification, and effective management of highly prevalent liver diseases such as NAFLD/NASH and their progression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

[Diagnosis and treatment of liver diseases in the era of artificial intelligence].
Ren LY, Chen DB, Chen HS. · · 2025 · PMID 41461549 · DOI 10.3760/cma.j.cn501113-20250910-00376

Verify or expand the search:

Other recruiting trials for NASH

Currently open trials in the same condition.

NCT07198386 — Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting
NCT07122700 — Evaluation of Non-Invasive Tests for Metabolic Liver Disease · recruiting
NCT06879236 — Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease · recruiting
NCT06705998 — To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects · Phase 1 · recruiting
NCT06410924 — A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH · Phase 2 · active not recruiting

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06888310 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 21 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06888310.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing