A Phase 2A, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk

Phase 2

Recruiting

• Conditions: cardiometabolic risk; obesity; 10018424

• Registration Number: NL-OMON36735
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Adult male
2. Age range 30-65 years at screening
3. Caucasian or Indian Ethnicity
4. Waist circumference * 102 cm for Caucasians and * 90 cm for Indians at screening.27
5. Fasting Serum Insulin * 10 mU/ml at screening
6. Blood Pressure 130/85 mmHg at screening(or patients taking medication for hypertension)
7. Stable weight during 3 months prior to the study (assessed through medical history of the patient)
8. Drug naïve 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

Exclusion Criteria

1. Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray (in India only) with any significant abnormalities, in the opinion of the investigator.
2. Subjects with any known somatic illness
3. Subject currently using medication, which can influence glucose or FFA metabolism such as fibrates, niacin, ACE inhibitors, PPAR agonists, omega 3 fatty acids.
4. eGFR < 60 mL/min/1.73m2 at screening
5. History of angina, Myocardial Infarction (MI) or stroke since last 6 months.
6. Hypertension with SBP/DBP *160/100 mm Hg at screening.
7. ALT or AST * ULN*3 at screening
8. Heavy smokers (who are smoking >15 cigarettes or equivalent per day).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Insulin Sensitivity:<br /><br>* Rate of Glucose Disposal<br /><br>* Suppression of Endogenous Glucose Production<br /><br>* Suppression of rate of lipolysis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Early efficacy markers that will be explored include:<br /><br>* Hepatic fat<br /><br>* Lipid parameters<br /><br>* Metabolic markers</p><br>