A Clinical Study to Test the Use of Cetilistat tablet in over weight individuals

Phase 3

Active, not recruiting

• Conditions: Obesity, unspecified,

• Registration Number: CTRI/2019/11/021919
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This is a phase III, double blind, double dummy, comparative, three-arm, active and placebo-controlled, parallel group, randomized, prospective, multicenter, efficacy and safety study. Adult male and female (18 – 65 years) patients with obesity who will meet all the inclusion criteria and none of the exclusion criteria will be included. Total study duration per patient: 18-20 weeks (maximum), depending on the screening period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-11
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Adult male or female patients aged of 18-65 years 2.
• The patient with body mass index (BMI) ≥30 kg/m2 3.
• Females of childbearing potential who are sexually active must agree to use barrier contraceptives 4.
• Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range.

Exclusion Criteria

• Patients with known hypersensitivity to any of the components of the study drugs 2.
• Patients with significant weight loss in the 3 months prior to screening 3.
• Patients with history of any serious systemic disease 4.
• Changes in the dosing of antihyperlipidemic or anti-diabetic drugs within 4 weeks of randomization 5.
• Patients with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, before 4 weeks of screening 6.
• Patients with history of anaphylaxis associated with medicinal products 7.
• History of drug or alcohol abuse within the past 2 years 8.
• Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization 9.
• Any other serious disease or condition at screening (or randomization) that would compromise patient safety 10.
• Patients with the current/past infections such as tuberculosis, hepatitis, herpes and/or patients with immune system disorders like HIV and SLE.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The absolute change in body weight	Week 12

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference	Week 12
Change in FPG	Week 12
Change in LDL	Week 12
Incidence of gastrointestinal adverse events	All Visits
Proportion of patients achieving 5% to 10% weight loss	Week 12

Trial Locations

Locations (4)

Grant Govt. Medical College & Sir JJ Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Kanoria Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Maharaja Agrasen Super Speciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Surya Super Speciality Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Grant Govt. Medical College & Sir JJ Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Hemant Ramsharan Gupta MD

Principal investigator

9820095763

drhemantgupta@hotmail.com