MedTrace Logo

To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia

NCT05852431 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-08-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Pegozafermin

Subcutaneous injection

DRUG

Placebo

Subcutaneous injection

Sponsors & Collaborators

  • 89bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Teresa Parli, MD · 89bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2025-07-07
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Latvia
  • Mexico
  • Poland
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852431 on ClinicalTrials.gov