NCT05798702 (FRIN) is a NA clinical trial of roux -en-y- gastric bypass in NASH With Fibrosis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT05798702?

NCT05798702 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT05798702?

Interventions in NCT05798702: roux -en-y- gastric bypass, intensive life style modification.

What condition does NCT05798702 study?

NCT05798702 studies NASH With Fibrosis, Weight Loss, Bariatric Surgery Candidate.

Is NCT05798702 still recruiting?

NCT05798702 is currently active, enrolled. Last updated 4 April 2023.

Last reviewed 2023-04-04 · How we verify

NCT05798702: FRIN

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

Fibrosis Reduction in Non Alcoholic Steatohepatitis

Active, enrolled NA Last updated 4 April 2023

What this trial tests

NA trial testing roux -en-y- gastric bypass in NASH With Fibrosis in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2021

Primary endpoint
1 September 2025

1 September 2026

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	1 September 2021
Primary completion	1 September 2025
Estimated completion	1 September 2026
Sites	1 location across Italy

Drugs / interventions tested

roux -en-y- gastric bypass
intensive life style modification

Conditions studied

NASH With Fibrosis — all drugs for NASH With Fibrosis →
Weight Loss — all drugs for Weight Loss →
Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 25 to 65, any sex, with NASH With Fibrosis or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Non-Alcoholic Steatohepatitis (NASH) represents one of the stages of Non-Alcoholic Fatty Liver Disease (NAFLD) with a very high risk to evolve in cirrhosis and hepato-carcinoma. Currently, the only diagnostic method is a liver biopsy that remains the gold standard for characterizing liver histologic alterations and fibrosis stages. There is no specific treatment for NASH, in fact no drugs are currently licensed specifically for treating this disease. Aim: Our aim is to conduct a non-inferiority, randomized-controlled trial (RCT) comparing Roux-en-Y Gastric bypass (RYGB) with an intensive lifestyle modification plan (Very low-calorie diet, VLCD) for the reduction of advanced stages of fibrosis in subjects with obesity and NASH after 25% weight loss.

Publications & conference data

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

A leap in the dark: Bariatric surgery for treatment of metabolic dysfunction-associated steatotic liver disease related cirrhosis: Editorial on "Bariatric surgery reduces long-term mortality in patients with metabolic dysfunction-associated steatotic liver disease and cirrhosis".
Zeng J, Fan JG. · · 2025 · cited 2× · PMID 39689704 · DOI 10.3350/cmh.2024.1099

Verify or expand the search:

Other recruiting trials for NASH With Fibrosis

Currently open trials in the same condition.

NCT07502755 — Non-invasive Tests for Non-alcoholic Steato-hepatitis · NA · active not recruiting
NCT04366999 — Effectiveness of Bariatric Surgery for NAFLD/NASH · 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 NCT05798702 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 4 April 2023

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/NCT05798702.

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