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Completed

NCT Number: NCT04541186

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

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Key information

Conditions

Severe Hypertriglyceridemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

89Bio Clinical Study Site, Pardubice, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pegozafermin

Drug

Subcutaneous injection

Other names: BIO89-100

Placebo

Drug

Matching placebo

Primary outcomes

  1. Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Number of Participants Who Achieved TG <500 mg/dL at Week 8

    Time frame: Week 8

  2. 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).

  3. Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG

    Time frame: Baseline, Week 8

  4. 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.

  5. 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).

  6. Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP)

    Time frame: Baseline, Week 8

  7. 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.

Sponsors and collaborators

Lead sponsor

89bio, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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