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Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541186
Recruitment Status : Completed
First Posted : September 9, 2020
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
89bio, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover 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
Actual Primary Completion Date : May 19, 2022
Actual Study Completion Date : May 31, 2022

Arm Intervention/treatment
Active Comparator: Main Study
The cohort will include subjects with SHTG without concurrent fibrate therapy and will consist of 5 treatment groups to compare 4 dose levels/regimens of BIO89-100 versus placebo.
Drug: BIO89-100
BIO89-100

Drug: Placebo
Placebo

Active Comparator: Fibrate Expansion Study
The cohort will include subjects with SHTG on stable background fibrate therapy and with a baseline MRI PDFF ≥6%, and will consist of 2 treatment groups comparing one dose regimen of BIO89 100 versus placebo.
Drug: BIO89-100
BIO89-100

Drug: Placebo
Placebo




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

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



Information from the National Library of Medicine

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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.
  5. MRI-PDFF of ≥6% for subjects screened for the fibrate expansion cohort.

Exclusion Criteria:

  1. Uncontrolled or newly diagnosed hypertension.
  2. Body mass index (BMI) >45 kg/m2.
  3. Receiving 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.

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


Locations
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United States, California
89Bio Clinical Study Site
La Mesa, California, United States, 91942
89Bio Clinical Study Site
San Francisco, California, United States, 94158
United States, Florida
89Bio Clinical Study Site
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 Lakes, Florida, United States, 33014
89Bio Clinical Study Site
Miami Lakes, Florida, United States, 33016
89Bio Clinical Study Site
Miami, Florida, United States, 33125
89Bio Clinical Study Site
Miami, Florida, United States, 33135
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
United States, Georgia
89Bio Clinical Study Site
Lawrenceville, Georgia, United States, 30044
United States, Illinois
89Bio Clinical Study Site
Quincy, Illinois, United States, 62301
89Bio Clinical Study Site
Wauconda, Illinois, United States, 60084
United States, Iowa
89Bio Clinical Study Site
West Des Moines, Iowa, United States, 50266
United States, Kentucky
89Bio Clinical Study Site
Louisville, Kentucky, United States, 40213
United States, Mississippi
89Bio Clinical Study Site
Olive Branch, Mississippi, United States, 38654
United States, New York
89Bio Clinical Study Site
Albany, New York, United States, 12203
United States, North Carolina
89Bio Clinical Study Site
Greensboro, North Carolina, United States, 27408
89Bio Clinical Study Site
Morganton, North Carolina, United States, 28655
United States, Ohio
89Bio Clinical Study Site
Marion, Ohio, United States, 43303
United States, South Carolina
89Bio Clinical Study Site
Summerville, South Carolina, United States, 29435
United States, Tennessee
89Bio Clinical Study Site
Chattanooga, Tennessee, United States, 37421
89Bio Clinical Study Site
Kingsport, Tennessee, United States, 37660
United States, Texas
89Bio Clinical Study Site
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
United States, Virginia
89Bio Clinical Study Site
Manassas, Virginia, United States, 20110
Czechia
89Bio Clinical Study Site
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
Hungary
89Bio Clinical Study Site
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
89Bio Clinical Study Site
Baja, Hungary
89Bio Clinical Study Site
Budapest, Hungary, 1032
89Bio Clinical Study Site
Békéscsaba, Hungary, 5600
89Bio Clinical Study Site
Debrecen, Hungary, 4032
Poland
89Bio Clinical Study Site
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
Sponsors and Collaborators
89bio, Inc.
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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: July 27, 2022
Last Verified: July 2022
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