A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity Disease
- Conditions
- Obesity
- Registration Number
- JPRN-jRCT2080223753
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 130
* Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
* BMI >= 25 kg/m2 combined with at least two obesity-related comorbidities, or BMI >= 35 kg/m2 at least one obesity-related comorbidity
* Patients with FPG >= 110 mg/dL and/or 5.6% <= HbA1c <= 10.0%, or T2DM with HbA1c <= 10.0%
* Waist circumference at umbilical level >= 85 cm for male, >= 90 cm for female
* Visceral fat area >= 100 cm2
* Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
* Pregnancy or lactating women
* Use of pharmacologically active weight-loss medications
* Bariatric surgery
* Ketoacidosis, lactic acidosis, hyperosmolar coma
* Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
* Gastro-intestinal (GI) disorders associated with chronic diarrhea
* Congestive heart failure, New York Heart Association (NYHA) class III or IV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Percent change from baseline in body weight at 12 week [ Time Frame: Baseline, Week 12 ]<br><br>the dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method