Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension

July 16, 2020 updated by: Torrent Pharmaceuticals Limited

A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects With Diabetes, Dyslipidemia and Hypertension

The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

TRC150094 is an Investigational Product for the treatment of CV risk associated with non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by increasing the energy expenditure and restoring mitochondrial flexibility which is deranged in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful benefits in well-established contributors of CV risk i.e., insulin resistance and hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP, over and above standard of care.

The phase III trial is designed with an aim of determining the efficacy of TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary Objectives of the study are,

  1. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension
  2. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension

In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.

Study Type

Interventional

Enrollment (Anticipated)

1250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Canoas, Brazil
        • Recruiting
        • Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS
        • Contact:
        • Contact:
      • Tatuí, Brazil
        • Recruiting
        • Rua Coronel Aureliano de Camargo,905, Centro,
        • Contact:
        • Contact:
    • Botafogo
      • Rio De Janeiro, Botafogo, Brazil, 22270-005
        • Recruiting
        • Comitê de ética em Pesquisa do Hospital Pró Cardíaco
        • Contact:
          • Luis Augusto Russo, MD PhD, MBA
          • Phone Number: 55 21 99988 0336
        • Contact:
          • Joselita S Bodart, MD, Physian
          • Phone Number: 55 21 986961073
    • CEP
      • São Paulo, CEP, Brazil, 01228-200
        • Recruiting
        • Avenida Angélica
        • Contact:
        • Contact:
    • SP
      • São Bernardo Do Campo, SP, Brazil, 09715-090 -
        • Recruiting
        • Rua Silva Jardim
        • Contact:
          • Claudia M de Brito, MD, Physian
          • Phone Number: 55 11 95369-9341
        • Contact:
          • Andrea S Audi, MD, Physian
          • Phone Number: 55 11 95369-9341
  • India
    • Gujarat
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Recruiting
        • Bangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,
        • Contact:
        • Contact:
    • Kerala
      • Calicut, Kerala, India, 673008
        • Recruiting
        • Government Medical College, Government Medical College Campus,
        • Contact:
        • Contact:
          • Dr.Chyandni R., MBBS,MD,PHD
      • Kochi, Kerala, India, 682017
        • Recruiting
        • Lisie Hospital
        • Contact:
        • Contact:
      • Thiruvananthapuram, Kerala, India, 695031
        • Recruiting
        • Indian Institute of Diabetes
        • Contact:
        • Contact:
    • Maharashtra
      • Nashik, Maharashtra, India, 422002
        • Recruiting
        • Supe Heart and Diabetes Hospital and Research Centre,
        • Contact:
        • Contact:
      • Pune, Maharashtra, India, 411007,
        • Recruiting
        • Medipoint Hospitals Pvt. Ltd
        • Contact:
        • Contact:
          • Shailaja G Bhatia, MBBS,MD
          • Phone Number: +919527016688
      • Ulhasnagar, Maharashtra, India, 421004
        • Recruiting
        • Ashirwad Hospital & Research Centre
        • Contact:
        • Contact:
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Recruiting
        • Dayanand Medical College & Hospital
        • Contact:
        • Contact:
          • damandeep P Kaur
          • Phone Number: 9814066999
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
      • Jaipur, Rajasthan, India, 302006
        • Recruiting
        • Diabetes ,Thyroid and Endocrine Centre
        • Contact:
        • Contact:
    • Telangana
      • Hyderabad, Telangana, India, 500029
        • Recruiting
        • Apollo Hospitals, PR No. 3-5-836 to 838, Near Old MLA Quarters,
        • Contact:
        • Contact:
  • Philippines
      • Davao City, Philippines, 8000
        • Recruiting
        • Davao Doctors Hospital
        • Contact:
          • Aquitania Grace, Int.Med
        • Contact:
          • Emily R Doliente, Int.Med
    • Cavite
    • Pampanga
    • Saint Iloilo City
      • General Luna, Saint Iloilo City, Philippines, 5000
        • Recruiting
        • St. Paul's Hospital
        • Contact:
          • Ygpuara M Lallaine, Int.Med
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects in the age range 30-70 years (both inclusive)
  2. BMI in the range 23-39 (inclusive) kg/m2
  3. HbA1C ≥7.5 %
  4. Stable therapy of ≤2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator.
  5. Non HDL-cholesterol ≥ 160 mg/dL.
  6. Mean Arterial Pressure (MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood pressure monitoring (ABPM) with or without antihypertensive treatment (subjects will have to be on stable dose of anti-hypertensive treatment for at least two months prior to screening); Dose should be appropriate for the duration of the study in the judgment of the investigator.
  7. Willing to give written informed consent
  8. Ability to adhere to the study restrictions and assessments schedule

Exclusion Criteria:

  1. Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of 24 hours' ambulatory blood pressure monitoring.
  2. HbA1C > 10 % at screening.
  3. Serum triglycerides >400 mg/dL.
  4. LDL-cholesterol >300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
  5. Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
  6. Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.
  7. Subjects having untreated thyroid dysfunction (TSH <0.3 or >5.5 µIU/mL) or hormone related obesity disorder.
  8. Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.
  9. eGFR <30 mL/min as evaluated by Modification of Diet in Renal Disease (MDRD) method.
  10. Seropositive for HIV, Hepatitis B or Hepatitis C.
  11. History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years.
  12. Pregnant or lactating women.
  13. Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
  14. Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
  15. Clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study.
  16. Intake of any investigational drug within 3 months prior to the first dose of study drug.
  17. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRC150094 45 mg
TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks
Drug: TRC150094
TRC150094 Tablet 45 mg
Placebo Comparator: Placebo
Matching Placebo Tablet to be administered orally once a day for 50 weeks
Drug: Placebo
Matching Placebo Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c
Time Frame: 24 Weeks
Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms
24 Weeks
Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score
Time Frame: 24 Weeks
Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MAP
Time Frame: 24 Weeks
Mean change in MAP from baseline to 24 weeks of treatment
24 Weeks
Change in non-HDL cholesterol
Time Frame: 24 Weeks
Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment
24 Weeks
Change in HbA1c
Time Frame: 24 Weeks
Mean change in HbA1c from baseline to 24 weeks of treatment
24 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: 24 Weeks
Mean change in weight from baseline to 24 weeks of treatment
24 Weeks
Safety profile of TRC150094
Time Frame: 50 Weeks
The safety profile of TRC150094 beyond 24 weeks of treatment shall also be reported
50 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torrent Pharmaceuticals Limited

Collaborators

Iqvia Pty Ltd

Investigators

  • Study Chair: Nikhil Tandon, M.D., PhD, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/P015/CMR/16/03_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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