Related Experiment Video
Updated: Jul 25, 2025
Mechanical and Controlled PRP Injections in Patients Affected by Androgenetic Alopecia
Published on: January 27, 2018
Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH
Rohit Loomba1, Arun J Sanyal1, Kris V Kowdley1
1From the NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla (R.L.), Velocity Clinical Research, Los Angeles (J.P.F.), and 89bio, San Francisco (M.D.G., S.F., G.D.A., C.L.H., H.M.); the Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond (A.J.S.); Liver Institute Northwest, Seattle (K.V.K.); Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York (D.L.B.); Arizona Liver Health, Chandler (N.A.); Liverpat, Paris (P.B.); Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom (S.A.H.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); ObjectiveHealth-Digestive Health Research, Nashville (D.L.); Ocala GI Research, Ocala, FL (R.B.); 89bio, Rehovot, Israel (M.M.); and the Division of Hepatobiliary Disease, Mayo Clinic, Rochester, MN (M.F.A.).
Pegozafermin demonstrated significant improvements in liver fibrosis and nonalcoholic steatohepatitis (NASH) resolution in a phase 2b trial. These findings support its further development for treating NASH.
Area of Science:
- Hepatology
- Pharmacology
- Clinical Trials
Background:
- Pegozafermin is an investigational fibroblast growth factor 21 (FGF21) analogue for nonalcoholic steatohepatitis (NASH).
- Its efficacy and safety in patients with biopsy-proven NASH require further establishment.
Purpose of the Study:
- To evaluate the efficacy and safety of pegozafermin in patients with biopsy-confirmed NASH and moderate to severe fibrosis.
- To assess fibrosis improvement and NASH resolution as primary endpoints.
Main Methods:
- A 24-week, phase 2b, randomized, placebo-controlled trial involving 222 patients with biopsy-confirmed NASH.
- Patients received weekly or bi-weekly subcutaneous pegozafermin (15 mg, 30 mg, or 44 mg) or placebo.
- Primary endpoints included fibrosis improvement (≥1 stage reduction) and NASH resolution without fibrosis worsening.
Main Results:
- Pegozafermin showed statistically significant improvements in fibrosis compared to placebo across tested doses (P ≤ 0.009).
- NASH resolution was observed in 23-37% of pegozafermin-treated patients versus 2% in the placebo group.
- Nausea and diarrhea were the most frequent adverse events associated with pegozafermin.
Conclusions:
- Pegozafermin treatment resulted in notable improvements in liver fibrosis in patients with NASH.
- The study supports advancing pegozafermin into phase 3 clinical development for NASH treatment.
More Related Videos
Related Concept Videos
01:18Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
01:23Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
01:24Glucagon-like Receptor Agonists
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...