Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Cetilistat 120mg tablet: Cetilistat 120mg tablets and matching placebo of orlistat 120mg capsules three times a day with each main meal (during or up to 1 hour after the meal) for 12 we
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change in body weightTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FPGTimepoint: Week 12;Change in LDLTimepoint: Week 12;Change in waist circumferenceTimepoint: Week 12;Incidence of gastrointestinal adverse eventsTimepoint: All Visits;Proportion of patients achieving 5% to 10% weight lossTimepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr SD Sinha
Hetero Labs Limited
Outcome results
None listed