Study to Explore the Efficacy & Safety of BIO89-100 in Subjects With

Updated 06/21/2024

Status Completed

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04541186
Study type	Interventional
Source	89bio, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	September 1, 2020
Completion date	May 31, 2022

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01208961` - Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation	Phase 2
	Active, not recruiting	`NCT05079919` - A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia	Phase 3
	Completed	`NCT02189252` - An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis	Phase 1
	Active, not recruiting	`NCT01229566` - Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia	Phase 3
	Completed	`NCT03001817` - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function	Phase 3
	Completed	`NCT03011450` - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment	Phase 3
	Completed	`NCT05355402` - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia	Phase 2
	Completed	`NCT04720534` - Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia	Phase 2
	Recruiting	`NCT06347016` - Study of Plozasiran in Adults With Severe Hypertriglyceridemia	Phase 3
	Recruiting	`NCT06347003` - Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia	Phase 3
	Withdrawn	`NCT04662528` - Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL	Phase 3
	Recruiting	`NCT05852431` - To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia	Phase 3
	Completed	`NCT01242527` - Epanova® for Lowering Very High Triglycerides	Phase 2/Phase 3
	Completed	`NCT02944383` - A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia	Phase 2
	Recruiting	`NCT05681351` - A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)	Phase 3
	Recruiting	`NCT05552326` - A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia	Phase 3
	Withdrawn	`NCT01997268` - The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)	Phase 3