NCT00776321

CompletedPhase 2

Eprotirome for the Treatment of Dyslipidemia, Efficacy and S...

Karo Bio AB Source

Karo Bio AB

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

EudraCT No: 2006-003191-35

Study Type

interventional

Actual enrollment (reported)

142

Locations

1 country

Sites

1

Timeline

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 142 participants
Study completion date: October 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2007
Actual (reported)
Study Completion
October 2007
Actual (reported)
First Submitted
October 17, 2008
Actual (reported)
First Posted
October 21, 2008
Actual (reported)

Last Updated: October 21, 2008
Status Verified: October 2008
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Karo Bio AB
Industrylead

Study Sites (1)

Jens Kristensen

Huddinge, Sweden

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

Enrollment

142 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

NCT00871351

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

Phase 4Completed

NCT00941603

Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

Phase 2Completed

NCT00746811

Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

Phase 4Completed

NCT04652349

Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

Phase 3Completed

NCT03413462

Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia

Phase 3Completed

Primary Completion

October 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

Last Updated

October 21, 2008

Record last verified: 2008-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00776321
Data provider: ClinicalTrials.gov
Source updated: 2008-10-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:28 UTC

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

Eprotirome dose 1

Eprotirome dose 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations