What side effects are associated with this type of intervention?

Common treatments for hypertriglyceridemia, such as fibrates (e.g., fenofibrate), omega-3 fatty acids, and statins, have various side effects. Fibrates can cause gastrointestinal issues, liver enzyme elevations, and muscle pain. Omega-3 fatty acids are generally well-tolerated but may cause a fishy aftertaste, gastrointestinal discomfort, and increased bleeding risk. Statins, while effective, can lead to muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Newer agents like Pegozafermin, a lipid-lowering agent, are being studied for their efficacy and safety, but detailed side effect profiles are still under investigation.

What prior FDA approvals exist?

The FDA has approved several lipid-lowering agents for the treatment of hypertriglyceridemia. These include fibrates (e.g., fenofibrate and gemfibrozil), which reduce triglyceride levels by activating peroxisome proliferator-activated receptors (PPARs); omega-3 fatty acid ethyl esters (e.g., icosapent ethyl), which lower triglycerides by reducing hepatic production of VLDL and triglycerides; and niacin, which decreases triglyceride synthesis. Statins, primarily used for lowering LDL cholesterol, also have a modest effect on triglycerides. These treatments are similar to Pegozafermin, which is being studied for its efficacy in lowering triglyceride levels.

What other types of research exist?

Promising novel alternatives to Pegozafermin for hypertriglyceridemia patients include: 1) Evinacumab, a monoclonal antibody targeting ANGPTL3, which has shown significant triglyceride-lowering effects. 2) Volanesorsen, an antisense oligonucleotide targeting APOC3, which has demonstrated efficacy in reducing triglyceride levels. 3) Pemafibrate, a selective PPARα modulator, which has been effective in lowering triglycerides and improving lipid profiles.

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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

Pivotal Trial

Summary

This trial is testing a medication called Pegozafermin to see if it can lower high levels of fats in the blood in people with severe hypertriglyceridemia. These patients have very high triglyceride levels, which can lead to serious health issues. The medication aims to reduce these fat levels to improve their health.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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I am on a consistent treatment plan for managing my cholesterol levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change from baseline in fasting TG

Secondary study objectives

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

17%

Abdominal Tenderness

17%

Increased Appetite

17%

Diarrhoea

Insomnia

Abdominal Distension

Gastritis

Gastrooesophageal Reflux Disease

Abdominal Pain

Gastroenteritis

Polyuria

Frequent Bowel Movements

Hypoglycaemia

Change of Bowel Habit

Thermal Burn

Wrist Fracture

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Pegozafermin 9 mg QW

Part 1: Pegozafermin 3 mg QW

Part 1: Placebo QW or Q2W

Part 1: Pegozafermin 27 mg QW

Part 1: Pegozafermin 18 mg Q2W

Part 1: Pegozafermin 36 mg Q2W

Part 1: Pegozafermin 18 mg QW

Part 2: Pegozafermin 27 mg QW

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~190

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hypertriglyceridemia include fibrates, omega-3 fatty acids, statins, and newer agents like Pegozafermin. Fibrates work by activating peroxisome proliferator-activated receptors (PPARs), which increase the oxidation of fatty acids and reduce triglyceride levels. Omega-3 fatty acids reduce hepatic triglyceride synthesis and increase triglyceride clearance. Statins primarily lower LDL cholesterol but also have modest triglyceride-lowering effects by inhibiting HMG-CoA reductase, reducing cholesterol synthesis. Pegozafermin, a newer lipid-lowering agent, is designed to reduce triglycerides by targeting specific pathways involved in lipid metabolism. These mechanisms are crucial for hypertriglyceridemia patients as they help lower triglyceride levels, reducing the risk of pancreatitis and cardiovascular diseases.