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Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

NCT04505436

CompletedPhase 2

Sponsor: Hanmi Pharmaceutical Company Limited

Conditions: NASH - Nonalcoholic Steatohepatitis

Interventions: HM15211, Placebo of HM15211

Countries: United States, South Korea

This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* United States Sites: Adults ≥ 18 to ≤ 70 years.
* Korean Sites: Adults ≥ 19 to ≤ 70 years.
* BMI ≥ 18 kg/m2, with stable body weight (defined as change \< 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
* Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
* MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria:

* Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
* Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease \>12.
* Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
* Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study
Locations (60)
  • Huntsville, Alabama, United States
  • Chandler, Arizona, United States
  • Chula Vista, California, United States
  • Fresno, California, United States
  • La Jolla, California, United States
  • Sacramento, California, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocala, Florida, United States
  • Orlando, Florida, United States
  • The Villages, Florida, United States
  • Chicago, Illinois, United States
  • New Albany, Indiana, United States
  • Topeka, Kansas, United States
  • Marrero, Louisiana, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Wyoming, Michigan, United States
  • Rochester, Minnesota, United States
  • Henderson, Nevada, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Morehead City, North Carolina, United States
  • Liberty Township, Ohio, United States
  • + 30 more on CT.gov