NCT00776321

Brief Summary

Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases. The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

1.1 years

First QC Date

October 17, 2008

Last Update Submit

October 20, 2008

Conditions

Primary Hypercholesterolemia

Keywords

hypercholesterolemiadyslipidemiathyroidsafety

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol

    Week 12

Secondary Outcomes (1)

  • Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes

    12 week

Study Arms (3)

1

PLACEBO COMPARATOR
Drug: Placebo

Eprotirome dose 1

EXPERIMENTAL
Drug: Eprotirome

Eprotirome dose 2

EXPERIMENTAL
Drug: Eprotirome

Interventions

EprotiromeDRUG
Also known as: KB2115
Eprotirome dose 1Eprotirome dose 2
PlaceboDRUG
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jens Kristensen

Huddinge, Sweden

Location

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemiasThyroid Diseases

Interventions

3-((3,5-dibromo-4-(4-hydroxy-3-(1-methylethyl)phenoxy)phenyl)amino)-3-oxopropanoic acid

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 21, 2008

Study Start

September 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

SE(1)