In a phase 2 randomized clinical trial in patients with severe hypertriglyceridemia, pegozafermin, a long-acting analog of human FGF21, was safe and met the primary endpoint of the trial for reducing serum triglyceride levels DLBHATTMD IcahnMountSinai
, LS mean percent change from baseline to week 8 in liver fat fraction assessed by MRI-PDFF., MRI-PDFF images depicting changes in liver fat fraction from representative participants with elevated baseline liver fat fraction defined as >25%., Proportion of participants who achieved liver fat normalization , ≥30% or ≥50% relative reduction in liver fat after 8 weeks.
Eligibility criteria allowed for the enrollment of participants on stabilized regimens of approved lipid-modifying therapies , such as statins, prescription fish oil and/or fibrates. Approximately 55% of participants enrolled were on background LMT, with a majority on a statin ), followed by prescription fish oil and fibrates .
, but the study was ultimately amended to include a fibrate cohort, with the additional criteria that those participants must have had at least 6% liver fat at baseline. Enrollment into this arm proved difficult and, therefore, participants on fibrates were likely underrepresented in the final study population relative to clinical practice.
. More recently, data from the Rochester Epidemiology Project showed that only 46% of patients with primary isolated hypertriglyceridemia ) have not demonstrated an add-on reduction in CV events in patients on statin therapy . For instance, while the REDUCE-IT trial did find a 25% reduction in a composite of CV events in high-risk patients, only part of the benefit was predicted by TG lowering, suggesting the outcomes were attributable to broader pleiotropic effects of IPE
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