NCT03254446

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Diabetes
• Dyslipidemias
• Hypertension

Interventions

Type	Name	Description
DRUG	TRC150094	TRC150094 Tablet 45 mg
DRUG	Placebo	Matching Placebo Tablet

Timeline

• Start date: 2018-03-12
• Primary completion: 2022-04-01
• Completion: 2022-08-01
• First posted: 2017-08-18
• Last updated: 2020-07-17

Locations

21 sites across 3 countries: Brazil, India, Philippines