Safety and efficacy of TRC150094 in reduction of risk for developing heart and metabolism related disorders in overweight/obese diabetic subjects with abnormal lipid profile.

Safety and efficacy of TRC150094 in treatment of cardio-metabolic risk in overweight/obese diabetic subjects with dyslipidemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/03/003444

Enrollment

225

Registered

2013-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Overweight/Obese, Diabetic subjects with dyslipidemia

Interventions

Intervention1: TRC150094: 25 mg Once daily oral administration for 24 weeks Intervention2: TRC150094: 50 mg Once daily oral administration for 24 weeks Intervention3: TRC150094: 75 mg Once daily oral

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects in the age range 30 year to 65 (Both inclusive)years Waist circumference in men >=90 cm and women >=80 cm BMI in the range 23-35 (inclusive) kg/m2 Fasting glucose >=126 mg/dL or HbA1C>=6.4 or stabilized on treatment with ApoB >= 100mg/dL Triglyceride >=150mg/dL Blood pressure SBP >=130 mmHg and DBP >=85 mmHg with or without anti-hypertensive treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoints Apo B Ambulatory BP Fasting Insulin and Fasting Glucose Timepoint: Baseline, Week 12 and Week 24	—

Secondary

Measure	Time frame
TG clearance after a standardized fat load Non-HDL Cholesterol and Apo B Apo A1 ratio Hepatic and Visceral Fat in sub set Timepoint: TG clearance after a standardized fat load at Baseline and Week 24 Non-HDL Cholesterol and Apo B Apo A1 ratio at Baseline Week 12 and Week 24 Hepatic and Visceral Fat in sub set at Baseline and Week 24	—

Countries

India

Contacts

Public ContactDr Shivani A Acharya

Torrent Pharmaceuticals Limited

ShivaniAcharya@torrentpharma.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 21, 2026