Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

June 30, 2024 updated by: 89bio, Inc.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia

This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (SHTG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Pardubice, Czechia, 530 02
        • 89bio Clinical Study Site
      • Prague, Czechia, 100 00
        • 89bio Clinical Study Site
      • Prague, Czechia, 150 00
        • 89bio Clinical Study Site
      • Prague, Czechia, 158 00
        • 89bio Clinical Study Site
      • Praha 4, Czechia, 14021
        • 89bio Clinical Study Site
  • Hungary
      • Baja, Hungary
        • 89bio Clinical Study Site
      • Budapest, Hungary, 1032
        • 89bio Clinical Study Site
      • Békéscsaba, Hungary, 5600
        • 89bio Clinical Study Site
      • Debrecen, Hungary, 4032
        • 89bio Clinical Study Site
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
        • 89bio Clinical Study Site
  • Poland
      • Białystok, Poland, 15-351
        • 89bio Clinical Study Site
      • Białystok, Poland, 15-879
        • 89bio Clinical Study Site
      • Lodz, Poland, 93-338
        • 89bio Clinical Study Site
      • Oswiecim, Poland, 32-600
        • 89bio Clinical Study Site
      • Rzeszów, Poland, 35-055
        • 89bio Clinical Study Site
      • Toruń, Poland, 87-100
        • 89bio Clinical Study Site
  • United States
    • California
      • La Mesa, California, United States, 91942
        • 89bio Clinical Study Site
      • San Francisco, California, United States, 94158
        • 89bio Clinical Study Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • 89bio Clinical Study Site
      • Greenacres City, Florida, United States, 33467
        • 89bio Clinical Study Site
      • Jacksonville, Florida, United States, 32205
        • 89bio Clinical Study Site
      • Miami, Florida, United States, 33125
        • 89bio Clinical Study Site
      • Miami, Florida, United States, 33135
        • 89bio Clinical Study Site
      • Miami Lakes, Florida, United States, 33014
        • 89bio Clinical Study Site
      • Miami Lakes, Florida, United States, 33016
        • 89bio Clinical Study Site
      • North Miami Beach, Florida, United States, 33162
        • 89bio Clinical Study Site
      • Orlando, Florida, United States, 32825
        • 89bio Clinical Study Site
      • Tampa, Florida, United States, 33606
        • 89bio Clinical Study Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30044
        • 89bio Clinical Study Site
    • Illinois
      • Quincy, Illinois, United States, 62301
        • 89bio Clinical Study Site
      • Wauconda, Illinois, United States, 60084
        • 89bio Clinical Study Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • 89bio Clinical Study Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • 89bio Clinical Study Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • 89bio Clinical Study Site
    • New York
      • Albany, New York, United States, 12203
        • 89bio Clinical Study Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • 89bio Clinical Study Site
      • Morganton, North Carolina, United States, 28655
        • 89bio Clinical Study Site
    • Ohio
      • Marion, Ohio, United States, 43303
        • 89bio Clinical Study Site
    • South Carolina
      • Summerville, South Carolina, United States, 29435
        • 89bio Clinical Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • 89bio Clinical Study Site
      • Kingsport, Tennessee, United States, 37660
        • 89bio Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78705
        • 89bio Clinical Study Site
      • Dallas, Texas, United States, 75204
        • 89bio Clinical Study Site
      • Dallas, Texas, United States, 77365
        • 89bio Clinical Study Site
      • Houston, Texas, United States, 77089
        • 89bio Clinical Study Site
      • Lampasas, Texas, United States, 76550
        • 89bio Clinical Study Site
      • Magnolia, Texas, United States, 77355
        • 89bio Clinical Study Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • 89bio Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female age ≥21 to ≤75 years.
  2. Screening fasting triglyceride ≥500 milligrams (mg)/deciliters (dL) and ≤2000 mg/dL.
  3. Willing to maintain current eating and exercise habits from time of signing the informed consent and for the duration of the study.
  4. Participants could be taking statins and/or prescription fish oil as background therapy or not be taking any background therapy.
  5. Magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) of ≥6% for participants screened for the Fibrate Expansion cohort.

Exclusion Criteria:

  1. Uncontrolled or newly diagnosed hypertension.
  2. Body mass index >45 kilograms (kg)/meters squared (m^2).
  3. Receiving niacin, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, or supplements that could lower lipid levels.
  4. Type 1 diabetes mellitus.
  5. Diagnosis of Type 2 diabetes mellitus <6 months prior to screening.
  6. History of malignancy within 5 years prior to screening.
  7. Participants with known lipoprotein lipase impairment or deficiency (Fredrickson Type 1), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type 3).
  8. Clinically or otherwise documented cardiovascular or cerebrovascular disease.
  9. Weight change ≥5% in 3 months prior to first screening visit or weight change ≥5% during screening or planning to try to lose weight during conduct of study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegozafermin 9 mg QW
Participants received pegozafermin 9 mg QW as an SC injection for 8 weeks in the Main Study cohort.
Drug: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Experimental: Pegozafermin 18 mg QW
Participants received pegozafermin 18 mg QW as an SC injection for 8 weeks in the Main Study cohort.
Drug: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Experimental: Pegozafermin 27 mg QW
Participants received pegozafermin 27 mg QW as an SC injection for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion pegozafermin 27 mg QW groups were pooled together due to low sample size in the expansion cohort.
Drug: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Experimental: Pegozafermin 36 mg Q2W
Participants received pegozafermin 36 mg Q2W as an SC injection for 8 weeks in the Main Study cohort.
Drug: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Placebo Comparator: Placebo
Matching placebo was injected at matching frequency per assigned cohort for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion placebo groups were pooled together due to low sample size in the expansion cohort.
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved TG <500 mg/dL at Week 8
Time Frame: Week 8
Week 8
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline, Week 8
Least Squares Means were calculated using mixed-model repeated measures (MMRM).
Baseline, Week 8
Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG
Time Frame: Baseline, Week 8
Baseline, Week 8
Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight
Time Frame: Baseline, Week 8
Least Squares Mean was calculated using MMRM.
Baseline, Week 8
Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF)
Time Frame: Baseline, Week 8
Least Squares Mean was calculated using analysis of covariance (ANCOVA).
Baseline, Week 8
Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP)
Time Frame: Baseline, Week 8
Baseline, Week 8
Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Time Frame: Baseline, Week 8
Least Squares Mean was calculated using MMRM.
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

89bio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

May 19, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

June 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO89-100-221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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