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

Phase 2

Completed

• Conditions: Health Condition 1: null- Overweight or obese prediabetic subjects with dyslipidemia

• Registration Number: CTRI/2013/03/003445
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

Male and female subjects in the age range 30-65 (both inclusive) years

Waist circumference in men >=90 cm and women >=80 cm

BMI in the range 23-35 (inclusive) kg/m2

ApoB >= 100 mg/dl

Triglyceride >=150mg/dl

Fasting Blood Glucose >= 100 mg/dl

Serum Insulin >= 12 µU/ml

Blood pressure: SBP >=130 mmHg and DBP >=85 mmHg with/ without anti-hypertensive treatment

Exclusion Criteria

SBP/DBP >=160/100 mmHg.

Subjects on Insulin therapy

Subjects having FPG 126 mg/dl or HbA1C 6.4 or on antidiabetic medication

Serum Triglycerides 400 mg/dL

LDL-Cholesterol 300 mg/dl or Medical History/clinical evidence of Familial Hyperlipidemic Disorder.

Subjects on anti-hyperlipidemic agents other than statins

History of angina, Myocardial Infarction (MI) or stroke within 6 months of screening

ALT or AST >= ULN 3 times

Alcohol intake (ethanol) 20 ml/day which is equivalent to 40 ml whisky/rum/gin/vodka/hard liquors or 240 ml of beer, or 90 ml of wine per day (averaged for 7 days).

eGFR 30 mL/min as evaluated by Cockroft-Gault method

Subjects having thyroid dysfunction (TSH 0.3 or 5.0) or euthyroid on thyroid medication or hormone related obesity disorder

Seropositive for HIV, Hepatitis B, Hepatitis C

Pregnant or lactating females.

History of Drug abuse

History of psychiatric disorder

History of any bleeding disorder

History of malignancy in last 3 years

Women of child bearing potential on Hormonal contraceptives for the duration of the study.

Clinically relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator, which would interfere with the objectives of the study.

Intake of any investigational drug within 3 months prior to first dose of study drug.

History of significant blood loss due to any reason, including blood donation, in the 12 weeks prior to the first dose of study drug; or the total blood loss in the last 3 months, including for this study, exceeds 450 ml

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apo B <br/ ><br>Ambulatory BP <br/ ><br>Fasting Insulin and Fasting Glucose <br/ ><br>Timepoint: Baseline, Week 12 and week 24 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Post-prandial glucose, Insulin & Triglyceride profile after standardized meal <br/ ><br>2. Non-HDL Cholesterol & Apo B/ Apo A1 <br/ ><br>3. Hepatic and Visceral Fat (in subset) <br/ ><br>Timepoint: 1. Post-prandial glucose, Insulin & Triglyceride profile after standardized meal at baseline and week24. <br/ ><br>2. Non-HDL Cholesterol & Apo B/ Apo A1 at baseline, week 12 and Week 24. <br/ ><br>3. Hepatic and Visceral Fat (in subset)at Baseline and Week 24. <br/ ><br>