CTRI/2021/12/038760招募中2 期
A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel, Dose Ranging, Proof Of Concept Study To Evaluate The Efficacy, Safety And Tolerability Of Fixed Dose Combination Of Naltrexone Hydrochloride And Zonisamide Sustained Release Capsules In Strengths Of 32mg/182mg, 32mg/273mg And 32mg/364mg In Comparison To Placebo In Weight Management Of Obese Subjects Or Overweight Subjects With Comorbidity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males and females aged between 18 and 65 years (both inclusive)
- •2. Subjects willing to provide written informed consent and comply with study instructions for its duration.
- •3. Body Mass Index (BMI) is
- •- 30 to 45 kg/m2 with or without a comorbid condition (e.g., type 2 diabetes, hypertension, dyslipidemia) or
- •- 27 to 29.9 kg/m2 with at least one comorbid condition.
- •Note: All subjects having at least 1 comorbid condition (i.e hypertension and/or dyslipidemia) should be stable on medications for respective conditions for at least 2 month before enrollment (Diabetic patients should be stable on medications for at least 3 months) and to continue same dose throughout the study.
- •4. Subjects who will be ambulatory and able to perform exercise programme and willing to follow dietary advice as documented through written informed consent.
- •5. 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.
- •6. Female subjects of
- •- Child-bearing potential should have negative serum pregnancy test prior to beginning the therapy and agree to use adequate birth control during the entire study period (acceptable methods include intrauterine device, barrier or abstinence). OR
- •- Post-menopausal for at least 01 year from the last menstrual date, OR
- •- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •1. Obesity secondary to known endocrine disorders (e.g. Hypothyroidism/ Cushing syndrome, Polycystic Ovarian disease)
- •2. Subjects with history of hypersensitivity to Sulphonamides or Zonisamide or Naltrexone or excipients.
- •3. Subjects with previous history of renal calculi.
- •4. Subjects with present or past history of major depression, bipolar disorder, psychosis, suicidal thoughts, binge eating disorder, epilepsy or other seizure disorder.
- •5. Subjects with known history or presence of Obstructive Sleep Apnoea (OSA) or at high risk of OSA based on STOP-Bang questionnaire.
- •6. Significant change in diet or level of physical activity within one month prior to randomization or change in weight of >4 kg within 3 months
- •7. Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding, liposuction etc.,) or anticipation of surgery during the study period that may interfere with completion or compliance of the protocol or any major surgeries in past 6 months.
- •8. Medication history that includes use of one or more of the following:
- •- Insulin analogues, Sulfonylurea, Meglitinides or medication prone to cause hypoglycemia (ongoing at screening that cannot be stopped for study period) - Use of other anti-obesity drugs (e.g. Lorcaserin or Orlistat etc., within 3 months prior to screening visit).
- •- Oral or parenteral corticosteroids, or Topiramate within 3 months of the screening visit.
- •- Chronic use of any opioid class of drugs (e.g., Morphine, Tramadol, Codeine, Loperamide etc.).
- •- Drugs that induce metabolism of CYP3A4 (e.g., Phenytoin, Rifampicin etc.,) or inhibit metabolism of CYP3A4 (e.g., Valproate, Ketoconazole etc.,)
- •- Use of antipsychotics, anti-anxiety (other than Benzodiazepines or Benzodiazepine like drugs), anti-depressants or mood stabilizers
- •- Hormonal contraceptives (ongoing at screening that cannot be stopped for study period)
- •- Thyroid Medications (e.g., Levothyroxine etc.,) (ongoing at screening that cannot be stopped for study period) - Anti-Thyroid Medications (e.g., Propyl Thiouracil, Methimazole etc.,) (ongoing at screening that cannot be stopped for study period)
- •9. Subjects currently dependent on opioids, including those currently maintained on opiate agonists (e.g. Methadone) or partial agonists (eg: Buprenorphine) and subjects in acute opiate withdrawal. Subject who has positive urine screen for opioids at screening visit
- •10. Subjects having following lab parameters deranged defined as follows
- •- Uncontrolled glycemia: HbA1C > 9%.
- •- Liver function impairment:
- •- AST, ALT Ë? 2.5Ã?ULN
- •- Alkaline Phosphatase Ë? 1.5Ã?ULN
- •- Total bilirubin Ë? 1.5Ã?ULN
- •- Renal function impairment:
- •- Creatinine Ë? 1.5Ã?ULN
- •- eGFR < 50 ml/min.
- •- Thyroid function tests:
- •- TSH > 2 x ULN or
- •- TSH < LLN and T4 > ULN
- •11. Subject with a score of more than Nineteen (19) in Beckâ??s Depression Inventory scale on screening.
- •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 etc.,)
- •13. Subjects with history of alcohol or pre-existing alcoholic liver disease or drug ab
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