Testing Survodutide for Liver Disease in Patients with NASH/MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Institute for Liver Health II DBA Arizona Clinical Trials
  Peoria, Arizona, United States Recruiting
• Scottsdale Medical Specialists, Ltd
  Scottsdale, Arizona, United States Recruiting
• Adobe Clinical Research, LLC
  Tucson, Arizona, United States Recruiting
• Arizona Liver Health - Tucson
  Tucson, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• Hope Clinical Research
  Canoga Park, California, United States Recruiting

+482 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving liver health through metabolic surgery or medication

  This study is testing whether metabolic surgery or medication can improve liver health in people with liver disease and obesity.

  Recruiting at 2 sites Phase 4 The Cleveland Clinic · Phoenix, Arizona and 21 other locations · NCT06374875

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• Umbilical cord stem cells added during Kasai to help biliary atresia

  This early-stage trial tests whether injecting umbilical cord mesenchymal stem cells during Kasai portoenterostomy is safe and helpful for infants with biliary atresia.

  Recruiting Phase 1 Dr Cipto Mangunkusumo General Hospital · Jakarta Pusat, DKI Jakarta · NCT07797673

• Pemvidutide for noncirrhotic MASH: a phase 3 study

  This phase 3 study tests pemvidutide versus placebo in adults with noncirrhotic MASH to see if it improves liver health and safety.

  Recruiting at 9 sites Phase 3 Altimmune, Inc. · North Little Rock, Arkansas and 8 other locations · NCT07795164

• VV-14303 for metabolic liver disease in adults with MASH

  This study tests VV-14303, a gene therapy, in adults with metabolic dysfunction-associated steatohepatitis (MASH) to see if it is safe and how well it works.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Chandler, Arizona and 2 other locations · NCT07732400

• HRS-4729 and HRS9531 injections in adults with MASH

  This study tests whether HRS-4729 and HRS9531 injections (and their placebos) can help adults with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

  Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07660848

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.