Clinical Trials

A randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of pegozafermin subjects with biopsy-confirmed nonalcoholic steatohepatitis (NASH)

ACTIVE, NOT RECRUITING

This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, efficacy, tolerability of pegozafermin in people with biopsy-confirmed fibrosis stages F2 or F3 NASH.

Eligibility criteria:

• People 21 to 75 years old
• Must have biopsy-confirmed NASH with fibrosis stage F2 or F3 and an NAS of 4 or more, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. (Biopsy must be within 6 months of screening or obtained during screening.)

Must NOT have:

• Uncontrolled high blood pressure
• Type 1 diabetes or uncontrolled type 2 diabetes
• History of cirrhosis or evidence of cirrhosis
• A plan to lose weight during the study
• BMI <25 kg/m2

Other criteria may apply.

Rohit Loomba MD, MHSc
Division of Gastroenterology and NAFLD Research Center, University of California at San Diego, La Jolla, CA

Deepak Bhatt MD, MPH, FACC, FAHA, FACAI, FESC
Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Juan Frias MD, FACE
Velocity Clinical Research, Los Angeles, CA

Naim Alkhouri MD
Arizona Liver Health, Phoenix, AZ

Kris Kowdley MD, FACP, FACG, AGAF, FAASLD
Liver Institute Northwest, Seattle, WA

Manal F. Abdelmalek, MD, MPH
Division of Gastroenterology/Hepatology, Mayo Clinic, Rochester, MN

A Phase 2, randomized, double-blind, placebo-controlled study to explore the efficacy and safety of pegozafermin in subjects with severe hypertriglyceridemia

COMPLETED

This study is looking at the efficacy, safety, and tolerability of different doses and dose regimens (every week or every 2 weeks) of pegozafermin in people with SHTG.

Eligibility criteria:

• People 21 to 75 years old
• Must have fasting triglyceride levels of 500–2000 mg/dL
• Must be willing to follow a lifestyle for optimal disease management during the study
• OK to be taking statins and/or prescription fish oil (but don’t have to be taking these to participate)

Must NOT have:

• Uncontrolled or newly diagnosed hypertension
• BMI >45 kg/m2
• A regimen that includes niacin, PCSK9 inhibitors, or supplements that could lower lipid levels
• Type 1 diabetes
• Type 2 diabetes diagnosed less than 6 months ago
• Cancer within the past 5 years
• Lipoprotein lipase impairment or deficiency (Fredrickson Type 1), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type 3)
• Cardiovascular or cerebrovascular disease
• Significant weight change in the past 3 months or planning to try to lose weight during the study

Other criteria may apply.

Michael Miller MD, FACC, FAHA
Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA

John Kastelein MD, PhD, FESC
Department of Vascular Medicine, Amsterdam UMD, University of Amsterdam, Amsterdam, the Netherlands

Harold Edward Bays MD, FOMA, FTOS, FACC, FNLA, FASPC
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY