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A Study in Participants With Non-cirrhotic NASH With Fibrosis
A Study in Participants With Non-cirrhotic NASH With Fibrosis

NCT05638737

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Interventions: AZD4831, Placebo

Countries: United States, Argentina, Denmark, Italy, Mexico, Norway, Portugal, Spain

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent.
2. Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosed by liver biopsy (within 12 months prior screening, participants without historical biopsy should be willing to undergo a liver biopsy at screening) fulfilling all of the following criteria:

   * NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation and ballooning
   * Presence of fibrosis F1, F2-F3
3. One increased serum ALT measurement (ALT \> ULN) at screening, and historical local serum ALT level (\> ULN \[41 U/L for men and 31 U/L for women\] but \< 300 U/L) on ≥ 1 occasion in the 6 months prior to screening.

Exclusion Criteria:

1. Liver disease of other etiologies (eg, alcoholic steatohepatitis; drug-induced, viral, or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha 1 antitrypsin deficiency; Wilson's disease).
2. History of excessive alcohol consumption, defined as an average weekly intake of \> 21 drinks/week for males or \> 14 drinks/week for females. One drink is equivalent to 14 g alcohol.
3. Recent (within 3 months of randomization) use of drugs approved for weight loss (eg, orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label.
4. High dose vitamin E (\> 400 IU) unless on a stable dose within 6 months of screening.
5. Recent (within 6 months of screening) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines).
6. Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.
Locations (65)
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Chula Vista, California, United States
  • Montclair, California, United States
  • Orange, California, United States
  • Redondo Beach, California, United States
  • Stanford, California, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Lakeland, Florida, United States
  • Miami, Florida, United States
  • Las Vegas, Nevada, United States
  • Yonkers, New York, United States
  • Morehead City, North Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • CABA, Argentina
  • CABA, Argentina
  • CABA, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Pilar, Argentina
  • Ramos Mejía, Argentina
  • Aarhus N, Denmark
  • Esbjerg, Denmark
  • København NV, Denmark
  • København Ø, Denmark
  • Køge, Denmark
  • Catania, Italy
  • + 35 more on CT.gov