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Pegozafermin for High Triglycerides (ENTRUST Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by 89bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥22 years
Willing to enter a lifestyle optimization period during the screening period and willing to maintain those eating and exercise habits for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

ENTRUST Trial Summary

This trial tested if Pegozafermin could reduce triglyceride levels in people with high levels of triglycerides.

Who is the study for?
This trial is for adults over 22 with severe hypertriglyceridemia, who are willing to follow a specific diet and exercise plan. They must be on stable lipid-modifying therapy but not have recent pancreatitis, uncontrolled diabetes, or infections like HBV, HCV, or HIV.Check my eligibility
What is being tested?
The study tests Pegozafermin's ability to lower fasting serum triglyceride levels in patients with high triglycerides after 26 weeks. Participants will either receive Pegozafermin or a placebo.See study design
What are the potential side effects?
Potential side effects of Pegozafermin may include digestive issues since it targets fat metabolism. However, the exact side effects aren't listed here; they'll be monitored throughout the trial.

ENTRUST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 22 years old or older.
Select...
I am on a consistent treatment plan for managing my cholesterol levels.

ENTRUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change from baseline in fasting TG
Secondary outcome measures
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Change in HbA1c at Week 26 for those with baseline ≥6.5%
Percent change from baseline in apolipoprotein B (apo-B)
+4 more

Side effects data

From 2022 Phase 1 & 2 trial • 101 Patients • NCT04048135
21%
Nausea
14%
Chest Pain
14%
Increased Appetite
14%
Headache
14%
Dysgeusia
7%
Abdominal Distension
7%
Upper Respiratory Tract Infection
7%
Vision Blurred
7%
Pruritus
7%
COVID-19
7%
Abdominal Discomfort
7%
Vomiting
7%
Seasonal Allergy
7%
Diarrhoea
7%
Neuropathy Peripheral
7%
Alanine Aminotransferase Increased
7%
Hyperglycaemia
7%
Urinary Tract Infection
7%
Dizziness
7%
Erythema
7%
Oropharyngeal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Pegozafermin 18 mg Q2W
Part 1: Placebo QW or Q2W
Part 1: Pegozafermin 18 mg QW
Part 2: Pegozafermin 27 mg QW
Part 1: Pegozafermin 3 mg QW
Part 1: Pegozafermin 9 mg QW
Part 1: Pegozafermin 27 mg QW
Part 1: Pegozafermin 36 mg Q2W

ENTRUST Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pegozafermin - 30mg once a weekExperimental Treatment1 Intervention
Group II: Pegozafermin - 20mg once a weekExperimental Treatment1 Intervention
Group III: Placebo once a weekPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegozafermin
2019
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor
5 Previous Clinical Trials
1,466 Total Patients Enrolled
1 Trials studying Hypertriglyceridemia
85 Patients Enrolled for Hypertriglyceridemia
Teresa Parli, MDStudy Director89bio, Inc.

Media Library

Pegozafermin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05852431 — Phase 3
Hypertriglyceridemia Research Study Groups: Pegozafermin - 20mg once a week, Placebo once a week, Pegozafermin - 30mg once a week
Hypertriglyceridemia Clinical Trial 2023: Pegozafermin Highlights & Side Effects. Trial Name: NCT05852431 — Phase 3
Pegozafermin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852431 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for participation in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial is currently enrolling participants and has been since May 1st 2023. It was recently updated on May 28th of this year and aims to receive 360 patients from 5 different sites."

Answered by AI

What is the hazard associated with a weekly administration of Pegozafermin - 30mg to patients?

"We rate the safety of Pegozafermin - 30mg once a week as 3 on a scale from 1 to 3, due to its Phase 3 status and prior evidence indicating both efficacy and security."

Answered by AI

Are there a number of sites hosting this clinical research experiment within the state?

"At present, individuals looking to partake in this clinical trial may do so at 5 distinct medical centres. These establishments are situated in Oviedo, Lawrenceville and Wichita among other cities; therefore it is advisable to choose the site nearest you for convenience reasons."

Answered by AI

How many participants are currently evaluating this study's efficacy?

"Indeed, clinicaltrials.gov has provided evidence that this medical investigation is actively recruiting individuals. This trial was initially posted on May 1st 2023 and most recently updated on the 28th of same month; 360 people are required from 5 different centres."

Answered by AI

Who else is applying?

What site did they apply to?
89Bio Clinical Study Site
89bio Clinical Study Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Tandem Clinical Research - Metairie, LA: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
2023. "To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852431.
All > Tandem > Tucson
~216 spots leftby Aug 2025
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