Trials / Active Not Recruiting
Active Not RecruitingNCT05852431
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- 89bio, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Pegozafermin | Subcutaneous injection |
| DRUG | Placebo | Subcutaneous injection |
Timeline
- Start date
- 2023-06-15
- Primary completion
- 2025-07-07
- Completion
- 2026-04-01
- First posted
- 2023-05-10
- Last updated
- 2025-08-07
Locations
177 sites across 20 countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, France, Georgia, Germany, Hungary, India, Italy, Latvia, Mexico, Poland, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05852431. Inclusion in this directory is not an endorsement.