The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction. In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Absolute weight loss compared to baseline
Proportion of patients achieving 5% or 10% weight loss
Changes in waist circumference
Changes in lipid profiles
Changes in markers of diabetes
Incidence of gastrointestinal adverse effects
Changes in other safety parameters
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