A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 89bio, Inc.
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)
研究概览
简要总结
This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (SHTG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥21 to ≤75 years.
- •Screening fasting triglyceride ≥500 milligrams (mg)/deciliters (dL) and ≤2000 mg/dL.
- •Willing to maintain current eating and exercise habits from time of signing the informed consent and for the duration of the study.
- •Participants could be taking statins and/or prescription fish oil as background therapy or not be taking any background therapy.
- •Magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) of ≥6% for participants screened for the Fibrate Expansion cohort.
排除标准
- •Uncontrolled or newly diagnosed hypertension.
- •Body mass index >45 kilograms (kg)/meters squared (m^2).
- •Receiving niacin, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, or supplements that could lower lipid levels.
- •Type 1 diabetes mellitus.
- •Diagnosis of Type 2 diabetes mellitus <6 months prior to screening.
- •History of malignancy within 5 years prior to screening.
- •Participants 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 first screening visit or weight change ≥5% during screening or planning to try to lose weight during conduct of study.
研究组 & 干预措施
Pegozafermin 9 mg QW
Participants received pegozafermin 9 mg QW as an SC injection for 8 weeks in the Main Study cohort.
干预措施: Pegozafermin (Drug)
Pegozafermin 18 mg QW
Participants received pegozafermin 18 mg QW as an SC injection for 8 weeks in the Main Study cohort.
干预措施: Pegozafermin (Drug)
Pegozafermin 27 mg QW
Participants received pegozafermin 27 mg QW as an SC injection for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion pegozafermin 27 mg QW groups were pooled together due to low sample size in the expansion cohort.
干预措施: Pegozafermin (Drug)
Pegozafermin 36 mg Q2W
Participants received pegozafermin 36 mg Q2W as an SC injection for 8 weeks in the Main Study cohort.
干预措施: Pegozafermin (Drug)
Placebo
Matching placebo was injected at matching frequency per assigned cohort for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion placebo groups were pooled together due to low sample size in the expansion cohort.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)
时间窗: Baseline, Week 8
次要结局
- Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG(Baseline, Week 8)
- Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP)(Baseline, Week 8)
- Number of Participants Who Achieved TG <500 mg/dL at Week 8(Week 8)
- Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 8)
- Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight(Baseline, Week 8)
- Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)(Baseline, Week 8)
- Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF)(Baseline, Week 8)