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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 14, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
Serum TG [ Time Frame: Week 8 ]
Percentage change in TG levels in subjects with SHTG (TG ≥500) mg/dL) from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Achieve TG <500 mg/dL [ Time Frame: Week 8 ]
    Proportion of subjects whose TG level is reduced to below 500 mg/dL levels
  • Very low-density lipoprotein cholesterol (VLDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • High-density lipoprotein cholesterol (HDL-C) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Very low-density lipoprotein triglycerides (VLDL-TG) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Apolipoprotein B100 (ApoB) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Remnant lipoprotein cholesterol (RLP-C) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Week 8 ]
    Percentage change from baseline
  • Fasting plasma glucose [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline
  • Fasting adiponectin [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline
  • Fasting plasma body weight [ Time Frame: Week 8 ]
    Percentage change in metabolic markers from baseline
  • Serum BIO89-100 concentration [ Time Frame: Week 8 ]
    Characterize PK parameters
  • Maximal observed serum concentrations (Cmax) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup
  • Area under the serum drug concentration [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup
  • Time to achieve Cmax (tmax) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup
  • Terminal elimination half-life (t1⁄2) [ Time Frame: Week 8 ]
    PK parameters in Intensive PK subgroup
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2020)
Liver Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: Week 8 ]
Percentage change in hepatic steatosis from baseline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Severe Hypertriglyceridemia
Intervention  ICMJE
  • Drug: BIO89-100
    BIO89-100
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Dose 1
    BIO89-100 administered subcutaneously
    Intervention: Drug: BIO89-100
  • Active Comparator: Dose 2
    BIO89-100 administered subcutaneously
    Intervention: Drug: BIO89-100
  • Active Comparator: Dose 3
    BIO89-100 administered subcutaneously
    Intervention: Drug: BIO89-100
  • Active Comparator: Dose 4
    BIO89-100 administered subcutaneously
    Intervention: Drug: BIO89-100
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Taffe 510-646-2328 Lisa.Taffe@89bio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04541186
Other Study ID Numbers  ICMJE BIO89-100-221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party 89bio, Inc.
Study Sponsor  ICMJE 89bio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 89bio, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP