Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: Survodutide for Metabolic Dysfunction Associated Steatohepatitis (MASH)

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. this study wants to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.

Official registry: https://clinicaltrials.gov/study/NCT06632444 · Boehringer Ingelheim · enrollment listed as 1,800

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Survodutide, or Placebo. The registry lists allocation as randomized. This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study.

They plan to enroll about 1,800 people at 532 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

Interventions: Survodutide, Placebo

Primary outcome (registry wording): Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent
  • Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
  • Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used
  • Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further who can join apply

Public study contact (from the registry)

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

532 listed

+ 367 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT06632444 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06632444?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06632444?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary