Effect of LAPS-Exendin on Body Weight in Obese Population

A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes

The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.

Phase 2 study

1. Inclusion Criteria:

   • Age: 18 years to 65 years
   • Genders: male and female
   • healthy obese population
   • non-diabetes
   • stable body weight for at least 3 months prior to screening

2. Exclusion Criteria

   • Pregnant or nursing (lactating) women
   • Drug-induced obesity
   • Diabetes mellitus (type 1, 2, and other)
   • Previous surgical treatment for obesity
   • Any known history of severe gastrointestinal (GI) disease or intolerance
   • Known history of pancreatitis with presence of raised serum amylase and lipase
   • History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium.