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.
RecruitingPhase 3interventionalRules rewrite

Phase 3: Survodutide for Metabolic Dysfunction Associated Steatohepatitis

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * body-mass index (BMI) of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study.

Official registry: https://clinicaltrials.gov/study/NCT06632457 · Boehringer Ingelheim · enrollment listed as 1,590

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 matching survodutide. The registry lists allocation as randomized. This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * body-mass index (BMI) of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian.

They plan to enroll about 1,590 people at 447 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Interventions: Survodutide, Placebo matching survodutide

Primary outcome (registry wording): Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
  • Body mass index (body-mass index (BMI)) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
  • Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis
  • 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

447 listed

+ 321 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06632457 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 NCT06632457?

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 NCT06632457?

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