A randomized, double-blind, dose-finding study to evaluate the change in weight after 24 weeks treatment with 8 doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo - To evaluate the change in weight after 24 weeks treatment with LIK066 in obese or overweight adults

ovartis Pharma AG0 个研究点目标入组 600 人开始时间: 2017年3月1日最近更新: 2018年10月1日

适应症

试验速览

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•1. informed consent.
•2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, prediabetes
•or type 2 diabetes mellitus, sleep-apnea syndrome).
•3. willing to comply with life-style intervention and treatment during the full duration of
•the study (approximately 54 weeks).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 416
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 184

•- Hypersensitivity to any of the study medications.
•- Pregnancy or lactating women.
•- History of malignancies.
•- Use of pharmacologically acitive weight loss products.
•- Bariatric surgery.
•- History of ketoacidosis, lactic acidosis, or hyperosmolar coma.
•- HbA1c >10% at the screening visit.
•- Symptomatic genital infection or urinary tract infection (UTI) in the 4 weeks prior to screening, or between screening and randomization.
•- Gastro-intestinal (GI) disorders associated with chronic diarrhea.
•- Congestive heart failure, New York Heart Association (NYHA) class III or IV.

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