A clinical study to study the effect of Lorcaserin tablets in the treatment of Obesity.
- Conditions
- Health Condition 1: null- Obesity
- Registration Number
- CTRI/2017/05/008655
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
1.Males or females aged between 18 and 65 years (both inclusive).
2.Body Mass Index (BMI) is 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes), or 27 to 29.9 kg/m2 with at least one comorbid condition.
3.Subjects with thyroid diseases on medications with stable thyroid functions for more than three months prior to screening.
4.Subjects willing to provide written informed consent and comply with study instructions for its duration.
5.Subject who will be ambulatory and able to perform exercise program.
6.Male subjects must be surgically sterile (i.e. vasectomy), for at least 3 months prior to screening or agree to use a condom when sexually active with a female partner who is not using an acceptable method of birth control.
7.Female subjects of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3 months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).
1. Subject who has clinically significant new illness in the 1 month before screening.
2.Subjects with history of Major Depression, Suicidal Thoughts, binge eating disorder, epilepsy or other seizure disorder.
3.History (within 2 years before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication (e.g., SSRIâ??s, SNRIâ??s [including buproprion], tricyclics, antipsychotics, lithium).
4.Significant change in diet or level of physical activity within 1 month prior to randomization or Change in weight of >5 kg within 3 months or use of very-low calorie ( < 1,000/day) liquid weight loss diet within 6 months.
5.Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding) or anticipation of surgery during the study period that may interfere with completion or compliance with the protocol.
6.Medication history that includes use of one or more of the following:
-Any use of fenfluramine or related derivatives (i.e., dexfenfluramine, norfenfluramine)
-Use of agents that have documented correlation with increased incidence of valvulopathy and/or primary pulmonary hypertension (e.g., Cyproheptadine, Trazodone, Nefazodone, Amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) within 5 years of the Screening Visit.
-Oral or parenteral corticosteroids, or topiramate within 3 months of the screening visit.
7.Subjects requiring any modification in dosage of thyroid medications (Hyper or Hypothyroidism) within last 3 months prior to screening.
8.Subjects with HbA1c > 9 %.
9.Subjects with Uncontrolled hypertension, defined as systolic blood pressure >=140 or diastolic blood pressure >= 90 mmHg.
10.Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 1.5x ULN) or renal function lab tests (e.g., creatinine greater than 1.25x ULN) suggestive of hepatic or renal impairment.
11.Subjects with abnormal thyroid screening lab values with T4 >ULN and TSH < LLN or TSH > 1.5x ULN.
12.Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents) or St. Johnâ??s Wort, or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat) or lipid dissolving injections (e.g., Lipodissolve).
13.Subjects with history of alcohol or drug abuse or smokers.
14.Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to the randomization.
15.Malignancy within 5 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
16.Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening.
17.Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol.
18.Subjects with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed the threshold limits set out for this study, the approval of Medical Monitor should be taken into co
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Percentage of subjects achieving â?¥ 5% body weight reduction at the end of 24 weeks of treatment from baseline.Timepoint: Baseline to week 24
- Secondary Outcome Measures
Name Time Method â?¢Mean change in body weight (kg) at the end of 24 weeks of treatment from baseline. <br/ ><br>â?¢Mean change in waist circumference from Baseline to Week 24. <br/ ><br>â?¢Mean change in blood pressure (systolic and diastolic) from Baseline to Week 24. <br/ ><br>â?¢Mean change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) from Baseline to Week 24. <br/ ><br>Timepoint: Baseline to week 24