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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04541186
Other study ID # BIO89-100-221
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2020
Est. completion date May 31, 2022

Study information

Verified date July 2022
Source 89bio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date May 31, 2022
Est. primary completion date May 19, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BIO89-100
BIO89-100
Placebo
Placebo

Locations

Country Name City State
Czechia 89Bio Clinical Study Site Pardubice
Czechia 89Bio Clinical Study Site Prague
Czechia 89Bio Clinical Study Site Prague
Czechia 89Bio Clinical Study Site Prague
Czechia 89Bio Clinical Study Site Praha 4
Hungary 89Bio Clinical Study Site Baja
Hungary 89Bio Clinical Study Site Békéscsaba
Hungary 89Bio Clinical Study Site Budapest
Hungary 89Bio Clinical Study Site Debrecen
Hungary 89Bio Clinical Study Site Miskolc Borsod-Abauj-Zemplen
Poland 89Bio Clinical Study Site Bialystok
Poland 89Bio Clinical Study Site Bialystok
Poland 89Bio Clinical Study Site Lodz
Poland 89Bio Clinical Study Site Oswiecim
Poland 89Bio Clinical Study Site Rzeszów
Poland 89Bio Clinical Study Site Torun
United States 89Bio Clinical Study Site Albany New York
United States 89Bio Clinical Study Site Austin Texas
United States 89Bio Clinical Study Site Chattanooga Tennessee
United States 89Bio Clinical Study Site Clearwater Florida
United States 89Bio Clinical Study Site Dallas Texas
United States 89Bio Clinical Study Site Dallas Texas
United States 89Bio Clinical Study Site Greenacres City Florida
United States 89Bio Clinical Study Site Greensboro North Carolina
United States 89Bio Clinical Study Site Houston Texas
United States 89Bio Clinical Study Site Jacksonville Florida
United States 89Bio Clinical Study Site Kingsport Tennessee
United States 89Bio Clinical Study Site La Mesa California
United States 89Bio Clinical Study Site Lampasas Texas
United States 89Bio Clinical Study Site Lawrenceville Georgia
United States 89Bio Clinical Study Site Louisville Kentucky
United States 89Bio Clinical Study Site Magnolia Texas
United States 89Bio Clinical Study Site Manassas Virginia
United States 89Bio Clinical Study Site Marion Ohio
United States 89Bio Clinical Study Site Miami Florida
United States 89Bio Clinical Study Site Miami Florida
United States 89Bio Clinical Study Site Miami Lakes Florida
United States 89Bio Clinical Study Site Miami Lakes Florida
United States 89Bio Clinical Study Site Morganton North Carolina
United States 89Bio Clinical Study Site North Miami Beach Florida
United States 89Bio Clinical Study Site Olive Branch Mississippi
United States 89Bio Clinical Study Site Orlando Florida
United States 89Bio Clinical Study Site Quincy Illinois
United States 89Bio Clinical Study Site San Francisco California
United States 89Bio Clinical Study Site Summerville South Carolina
United States 89Bio Clinical Study Site Tampa Florida
United States 89Bio Clinical Study Site Wauconda Illinois
United States 89Bio Clinical Study Site West Des Moines Iowa

Sponsors (1)

Lead Sponsor Collaborator
89bio, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Poland, 

Outcome

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