Effect of LAPS-Exendin on Body Weight in Obese Population
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 8/10/2016 |
| Start Date: | February 2014 |
| End Date: | February 2015 |
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.
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.
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