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Testing Survodutide for Liver Disease in Patients with NASH/MASH

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

Phase 3 Interventional Boehringer Ingelheim · NCT06632444

This study is testing a new medication called survodutide to see if it can help adults with liver disease related to metabolic dysfunction feel better and improve their liver health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1800 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations525 sites (Birmingham, Alabama and 524 other locations)
Trial IDNCT06632444 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a medication called survodutide in adults diagnosed with metabolic dysfunction associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. The study is divided into two parts: the first part assesses the impact of survodutide on MASH and liver fibrosis, while the second part focuses on its safety and efficacy in improving liver function. Participants will be randomly assigned to receive either survodutide or a placebo, with the goal of determining the potential benefits of the treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of MASH and moderate to advanced liver fibrosis.

Not a fit: Patients with other acute or chronic liver diseases or significant alcohol intake may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver function and overall health for patients suffering from MASH and liver fibrosis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating liver diseases with novel medications.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. 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
2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
3. 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
4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

Exclusion criteria:

1. Any of the following liver laboratory test abnormalities at screening:

   * Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
   * Platelet count \<140 000/mm\^3 (\<140 GI/L)
   * Alkaline phosphatase \>2x upper limit of normal (ULN)
   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:

     * Albumin below \<3.5 g/dL (35.0 g/L)
     * OR International normalised ratio (INR) of prothrombin time \>1.3
     * OR total serum bilirubin concentration ≥1.5x ULN
2. Any history or evidence of acute or chronic liver disease other than MASH
3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
4. History of or current diagnosis of hepatocellular carcinoma
5. History of or planned liver transplant
6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
7. History of portal hypertension or presence of decompensated liver disease
8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply

Where this trial is running

Birmingham, Alabama and 524 other locations

+475 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metabolic Dysfunction Associated SteatohepatitisLiver Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.