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

Primary Purpose

Severe Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIO89-100
Placebo
Sponsored by
89bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia focused on measuring Hypertriglyceridemia, Dyslipidemia, Lipid disorder, FGF21

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site
  • 89Bio Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Main Study

Fibrate Expansion Study

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Serum TG
Percentage change in TG levels in subjects with SHTG (TG ≥500) mg/dL) from baseline

Secondary Outcome Measures

Achieve TG <500 mg/dL
Proportion of subjects whose TG level is reduced to below 500 mg/dL levels
Very low-density lipoprotein cholesterol (VLDL-C)
Percentage change from baseline
Low-density lipoprotein cholesterol (LDL-C)
Percentage change from baseline
Non-high-density lipoprotein cholesterol (non-HDL-C)
Percentage change from baseline
High-density lipoprotein cholesterol (HDL-C)
Percentage change from baseline
Very low-density lipoprotein triglycerides (VLDL-TG)
Percentage change from baseline
Apolipoprotein B100 (ApoB)
Percentage change from baseline
Remnant lipoprotein cholesterol (RLP-C)
Percentage change from baseline
high-sensitivity C-reactive protein (hsCRP)
Percentage change from baseline
Fasting plasma glucose
Percentage change in metabolic markers from baseline
Fasting adiponectin
Percentage change in metabolic markers from baseline
Fasting plasma body weight
Percentage change in metabolic markers from baseline
Serum BIO89-100 concentration
Characterize PK parameters
Maximal observed serum concentrations (Cmax)
PK parameters in Intensive PK subgroup
Area under the serum drug concentration
PK parameters in Intensive PK subgroup
Time to achieve Cmax (tmax)
PK parameters in Intensive PK subgroup
Terminal elimination half-life (t1⁄2)
PK parameters in Intensive PK subgroup
Liver Proton Density Fat Fraction (MRI-PDFF)
Percentage change in hepatic steatosis from baseline

Full Information

First Posted
August 14, 2020
Last Updated
July 26, 2022
Sponsor
89bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04541186
Brief Title
Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
89bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
Keywords
Hypertriglyceridemia, Dyslipidemia, Lipid disorder, FGF21

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Main Study
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fibrate Expansion Study
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BIO89-100
Intervention Description
BIO89-100
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Serum TG
Description
Percentage change in TG levels in subjects with SHTG (TG ≥500) mg/dL) from baseline
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Achieve TG <500 mg/dL
Description
Proportion of subjects whose TG level is reduced to below 500 mg/dL levels
Time Frame
Week 8
Title
Very low-density lipoprotein cholesterol (VLDL-C)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Non-high-density lipoprotein cholesterol (non-HDL-C)
Description
Percentage change from baseline
Time Frame
Week 8
Title
High-density lipoprotein cholesterol (HDL-C)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Very low-density lipoprotein triglycerides (VLDL-TG)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Apolipoprotein B100 (ApoB)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Remnant lipoprotein cholesterol (RLP-C)
Description
Percentage change from baseline
Time Frame
Week 8
Title
high-sensitivity C-reactive protein (hsCRP)
Description
Percentage change from baseline
Time Frame
Week 8
Title
Fasting plasma glucose
Description
Percentage change in metabolic markers from baseline
Time Frame
Week 8
Title
Fasting adiponectin
Description
Percentage change in metabolic markers from baseline
Time Frame
Week 8
Title
Fasting plasma body weight
Description
Percentage change in metabolic markers from baseline
Time Frame
Week 8
Title
Serum BIO89-100 concentration
Description
Characterize PK parameters
Time Frame
Week 8
Title
Maximal observed serum concentrations (Cmax)
Description
PK parameters in Intensive PK subgroup
Time Frame
Week 8
Title
Area under the serum drug concentration
Description
PK parameters in Intensive PK subgroup
Time Frame
Week 8
Title
Time to achieve Cmax (tmax)
Description
PK parameters in Intensive PK subgroup
Time Frame
Week 8
Title
Terminal elimination half-life (t1⁄2)
Description
PK parameters in Intensive PK subgroup
Time Frame
Week 8
Title
Liver Proton Density Fat Fraction (MRI-PDFF)
Description
Percentage change in hepatic steatosis from baseline
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age ≥21 to ≤75 years. Screening fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL. Willing to follow a lifestyle for optimal control of TGs and disease management during the study. Patients could be taking statins and/or prescription fish oil as background therapy OR not be taking any background therapy. MRI-PDFF of ≥6% for subjects screened for the fibrate expansion cohort. Exclusion Criteria: Uncontrolled or newly diagnosed hypertension. Body mass index (BMI) >45 kg/m2. Receiving niacin, PCSK9 inhibitors, or supplements that could lower lipid levels. Type 1 diabetes mellitus (T1DM). Diagnosis of Type 2 diabetes mellitus (T2DM) <6 months prior to screening. History of malignancy within 5 years prior to screening. Subjects 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 screening visit 1 or weight change ≥5% during screening or planning to try to lose weight during conduct of study.
Facility Information:
Facility Name
89Bio Clinical Study Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
89Bio Clinical Study Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
89Bio Clinical Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
89Bio Clinical Study Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
89Bio Clinical Study Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
89Bio Clinical Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
89Bio Clinical Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
89Bio Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
89Bio Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
89Bio Clinical Study Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
89Bio Clinical Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
89Bio Clinical Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
89Bio Clinical Study Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Facility Name
89Bio Clinical Study Site
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
89Bio Clinical Study Site
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Facility Name
89Bio Clinical Study Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
89Bio Clinical Study Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
89Bio Clinical Study Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
89Bio Clinical Study Site
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
89Bio Clinical Study Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
89Bio Clinical Study Site
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
89Bio Clinical Study Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43303
Country
United States
Facility Name
89Bio Clinical Study Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29435
Country
United States
Facility Name
89Bio Clinical Study Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
89Bio Clinical Study Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
89Bio Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
89Bio Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
89Bio Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
77365
Country
United States
Facility Name
89Bio Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
89Bio Clinical Study Site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
89Bio Clinical Study Site
City
Magnolia
State/Province
Texas
ZIP/Postal Code
77355
Country
United States
Facility Name
89Bio Clinical Study Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
89Bio Clinical Study Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
89Bio Clinical Study Site
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
89Bio Clinical Study Site
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
89Bio Clinical Study Site
City
Prague
ZIP/Postal Code
158 00
Country
Czechia
Facility Name
89Bio Clinical Study Site
City
Praha 4
ZIP/Postal Code
14021
Country
Czechia
Facility Name
89Bio Clinical Study Site
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
89Bio Clinical Study Site
City
Baja
Country
Hungary
Facility Name
89Bio Clinical Study Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
89Bio Clinical Study Site
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
89Bio Clinical Study Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
89Bio Clinical Study Site
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
89Bio Clinical Study Site
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
89Bio Clinical Study Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
89Bio Clinical Study Site
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
89Bio Clinical Study Site
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
89Bio Clinical Study Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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