A Phase 3 interventional study of Pegozafermin and Placebo in Severe Hypertriglyceridemia, sponsored by 89bio, Inc.. Completed at 177 sites in 20 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by 89bio, Inc. · Phase 3, Interventional, and Treatment
To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 369 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →89bio, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pegozafermin
Drug: Pegozafermin
Drug: Placebo
Subcutaneous injection
Subcutaneous injection
Percent change from baseline in fasting TG
Time frame: 26 weeks
Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: 26 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: 26 weeks
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
Time frame: 26 weeks
Percent change from baseline in total cholesterol (TC)
Time frame: 26 weeks
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Time frame: 26 weeks
Percent change from baseline in apolipoprotein B (apo-B)
Time frame: 26 weeks
Change in HbA1c at Week 26 for those with baseline ≥7.0%
Time frame: 26 weeks
Percent change from baseline in fasting TG
Time frame: 52 weeks
Showing the first 100 of 177 sites across 20 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Jul 2025, 24 months.
Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's 24 months is close to that.
Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegozafermin
89bio, Inc.