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Trial record 2 of 26 for:    severe hypertriglyceridemia
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Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT04541186
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
89bio, Inc.

Study Description
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Brief Summary:
This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (QW or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 compared to placebo in subjects with Severe Hypertriglyceridemia (SHTG).

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: BIO89-100 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dose 1
BIO89-100 administered subcutaneously
 Drug: BIO89-100
BIO89-100
Active Comparator: Dose 2
BIO89-100 administered subcutaneously
 Drug: BIO89-100
BIO89-100
Active Comparator: Dose 3
BIO89-100 administered subcutaneously
 Drug: BIO89-100
BIO89-100
Active Comparator: Dose 4
BIO89-100 administered subcutaneously
 Drug: BIO89-100
BIO89-100
Placebo Comparator: Placebo
Placebo administered subcutaneously
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Serum TG [ Time Frame: Week 8 ]
    Percentage change in TG levels in subjects with SHTG (TG ≥500) mg/dL) from baseline


Secondary Outcome Measures :
  1. Achieve TG <500 mg/dL [ Time Frame: Week 8 ]
    Proportion of subjects whose TG level is reduced to below 500 mg/dL levels

  2. Very low-density lipoprotein cholesterol (VLDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline

  3. Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline

  4. Non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline

  5. High-density lipoprotein cholesterol (HDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline

  6. Very low-density lipoprotein triglycerides (VLDL-TG) [ Time Frame: Week 8 ]
    Percentage change from baseline

  7. Apolipoprotein B100 (ApoB) [ Time Frame: Week 8 ]
    Percentage change from baseline

  8. Remnant lipoprotein cholesterol (RLP-C) [ Time Frame: Week 8 ]
    Percentage change from baseline

  9. high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Week 8 ]
    Percentage change from baseline

  10. Fasting plasma glucose [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline

  11. Fasting adiponectin [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline

  12. Fasting plasma body weight [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline

  13. Serum BIO89-100 concentration [ Time Frame: Week 8 ]
    Characterize PK parameters

  14. Maximal observed serum concentrations (Cmax) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup

  15. Area under the serum drug concentration [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup

  16. Time to achieve Cmax (tmax) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup

  17. Terminal elimination half-life (t1⁄2) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup


Other Outcome Measures:
  1. Liver Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: Week 8 ]
    Percentage change in hepatic steatosis from baseline


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age ≥21 to ≤75 years.
  2. Screening fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL.
  3. Willing to follow a lifestyle for optimal control of TGs and disease management during the study.
  4. Patients could be taking statins and/or prescription fish oil as background therapy OR not be taking any background therapy.

Exclusion Criteria:

  1. Uncontrolled hypertension.
  2. Body mass index (BMI) >45 kg/m2.
  3. Receiving fibrates, niacin, PCSK9 inhibitors, or supplements that could lower lipid levels.
  4. Type 1 diabetes mellitus (T1DM).
  5. Diagnosis of Type 2 diabetes mellitus (T2DM) <6 months prior to screening.
  6. History of malignancy within 5 years prior to screening.
  7. Subjects 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 screening visit 1 or weight change ≥5% during screening or planning to try to lose weight during conduct of study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541186


Contacts
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Contact: Lisa Taffe 510-646-2328 Lisa.Taffe@89bio.com

Locations
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Sponsors and Collaborators
89bio, Inc.
More Information
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Responsible Party: 89bio, Inc.
ClinicalTrials.gov Identifier: NCT04541186    
Other Study ID Numbers: BIO89-100-221
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 89bio, Inc.:
Hypertriglyceridemia
Dyslipidemia
Lipid disorder
FGF21
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases