A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)

Phase 1

Completed

• Conditions: Elevated Lp(a)
• Interventions: Drug: TA-8995; Drug: Placebo

• Registration Number: NCT02241772
• Lead Sponsor: Xention Ltd

Brief Summary

A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-20
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Status Verified: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels

Exclusion Criteria

• Clinically significant medical history
• Abnormal laboratory results (other than lipid levels) or vital signs
• Receiving any other drug therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10mg TA-8995	TA-8995	10mg TA-8995 once daily
2.5mg TA-8995	TA-8995	2.5mg TA-8995 once daily
Placebo to TA-8995	Placebo	Placebo to TA-8995 once daily.

Primary Outcome Measures

Name	Time	Method
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	12 weeks

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark