NCT01408667

Brief Summary

The purpose of the study is to determine the safety and efficacy of TRC150094 in male patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL cholesterol, insulin resistance, dysglycemia and visceral obesity.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 29, 2011

Last Update Submit

July 6, 2012

Conditions

Metabolic Cardiovascular Syndrome

Keywords

insulin sensitivitycardiometabolic riskhyperinsulinemic euglycemic clamp

Outcome Measures

Primary Outcomes (2)

  • The safety of TRC150094 once daily dosing for 4 weeks in male patients with increased cardiometabolic risk will be determined.

    Safety parameters will include haematology, safety biochemistry, vital signs, ECG and AE check.

    1 month

  • The efficacy (in increasing insulin sensitivity) of TRC150094 once daily dosing for 4 weeks in male patients with increased cardiometabolic risk will be determined.

    Efficacy assessment will include Insulin Sensitivity to be determined by: Rate of Glucose Disposal Suppression of Endogenous Glucose Production Suppression of rate of lipolysis

    1 month

Secondary Outcomes (2)

  • The effect of TRC150094 on hepatic fat and metabolic parameters will be evaluated.

    1 month

  • The ethnic differences for effect of TRC150094 on Insulin sensitivity parameters will be evaluated.

    1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

TRC150094

ACTIVE COMPARATOR
Drug: TRC150094

Interventions

TRC150094DRUG

50 mg Tablets once a day

TRC150094
PlaceboOTHER

Tablets once daily

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be considered eligible for entry in the study if they meet all of the following criteria.
  • Adult male
  • Age range 30-65 years at screening
  • Caucasian or Indian ethnicity
  • Waist circumference ≥ 102 cm for Caucasians and ≥ 90 cm for Indians at screening.
  • Fasting Serum Insulin ≥ 10 mU/ml at screening
  • Blood Pressure ≥ 130/85 mmHg at screening (or patients taking medication for hypertension)
  • Stable weight during 3 months prior to the study (assessed through medical history of the patient)
  • Drug naive diabetic patients\* or patients with impaired fasting glucose i.e \> 100 mg/dl or 5.5 mmol/l and \< 200 mg/dl or 11.0 mmol/l Diabetic patients who were taking metformin and have undergone washout for at least 4 weeks before Day 0 and are currently on life style modification as a treatment for diabetes will also be allowed in the study
  • Willingness to give written informed consent (prior to any study-related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.
  • Diabetic patient is defined as a patient with a documented history of type II DM or a documented history of a fasting glucose \> 200mg/dl or 11.0 mmol/l or 2x fasting glucose \> 126 mg/dl or 6.9 mmol/l (2x =recorded twice).

You may not qualify if:

  • Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
  • Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray (to exclude tuberculosis in India only) with any significant abnormalities, in the opinion of the investigator.
  • Subjects with any known somatic illness, including neoplasm, endocrine disorder such as cushing's disease, PCOD and uncontrolled hypothyroidism, neurologic disorder, active infection, or recent surgical procedure within 3 months of the study initiation.
  • Subject currently using medication, which can influence glucose or FFA metabolism such as fibrates, niacin, ACE inhibitors, PPAR agonists, omega 3 fatty acids.
  • eGFR \< 60 mL/min/1.73m2 at screening as evaluated by Modification of Diet in Renal Disease (MDRD) method.
  • History of angina, Myocardial Infarction (MI) or stroke since last 6 months.
  • Hypertension with SBP/DBP ≥160/100 mmHg at screening.
  • ALT or AST ≥ ULN\*3 at screening
  • History or presence of malignancy.
  • History of recreational drug use within the last 30 days, or regular consumption of greater than 2 units of alcohol/day.
  • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  • Seropositive for Hepatitis B, Hepatitis C or HIV.
  • Subjects suffering from any psychiatric (acute or chronic) illness.
  • Intake of any medication except those permitted in this study (see Section 6.6).
  • Intake of any investigational drug in the period within 3 months prior to the first dose of study drug.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre,

Amsterdam, Amsterdam, 1100 DD, Netherlands

Location

Related Publications (3)

  • Zambad SP, Munshi S, Dubey A, Gupta R, Busiello RA, Lanni A, Goglia F, Gupta RC, Chauthaiwale V, Dutt C. TRC150094 attenuates progression of nontraditional cardiovascular risk factors associated with obesity and type 2 diabetes in obese ZSF1 rats. Diabetes Metab Syndr Obes. 2011 Jan 6;4:5-16. doi: 10.2147/DMSOTT.S15323.

    PMID: 21448317BACKGROUND

  • Cioffi F, Zambad SP, Chhipa L, Senese R, Busiello RA, Tuli D, Munshi S, Moreno M, Lombardi A, Gupta RC, Chauthaiwale V, Dutt C, de Lange P, Silvestri E, Lanni A, Goglia F. TRC150094, a novel functional analog of iodothyronines, reduces adiposity by increasing energy expenditure and fatty acid oxidation in rats receiving a high-fat diet. FASEB J. 2010 Sep;24(9):3451-61. doi: 10.1096/fj.10-157115. Epub 2010 May 7.

    PMID: 20453112BACKGROUND

  • van der Valk F, Hassing C, Visser M, Thakkar P, Mohanan A, Pathak K, Dutt C, Chauthaiwale V, Ackermans M, Nederveen A, Serlie M, Nieuwdorp M, Stroes E. The effect of a diiodothyronine mimetic on insulin sensitivity in male cardiometabolic patients: a double-blind randomized controlled trial. PLoS One. 2014 Feb 21;9(2):e86890. doi: 10.1371/journal.pone.0086890. eCollection 2014.

    PMID: 24586256DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Interventions

TRC150094

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Erik Stroes, MD, PhD

    Department of Vascular Medicine, AMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 3, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

NL(1)