Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

NCT06318169

RecruitingPhase 3

Sponsor: 89bio, Inc.

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions: Pegozafermin, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH with fibrosis stage F2 or F3
* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).

Key Exclusion Criteria:

* Chronic liver diseases other than MASH
* Evidence of cirrhosis on screening liver biopsy
* Have type 1 diabetes or poorly controlled type 2 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.
Locations (365)
  • Birmingham, Alabama, United States
  • Chandler, Arizona, United States
  • Flagstaff, Arizona, United States
  • Glendale, Arizona, United States
  • Sun City, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Conway, Arkansas, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Canoga Park, California, United States
  • Coronado, California, United States
  • Escondido, California, United States
  • Fountain Valley, California, United States
  • Fresno, California, United States
  • Gardena, California, United States
  • Huntington Park, California, United States
  • Inglewood, California, United States
  • La Jolla, California, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Montclair, California, United States
  • Orange, California, United States
  • Panorama City, California, United States
  • Pasadena, California, United States
  • Poway, California, United States
  • Rialto, California, United States
  • Santa Ana, California, United States
  • Stanford, California, United States
  • + 335 more on CT.gov