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

Severe Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541186
• Other study ID #: BIO89-100-221
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Severe Hypertriglyceridemia

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