Effect of LAPS-Exendin on Body Weight in Obese Population

Study Overview
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Brief Summary
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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.

Detailed Description
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Phase 2 study

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Biological: HM11260C
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM11260C<br>HM11260C 4 mg weekly sc injection | Biological: HM11260C<br>* Glucagon-like peptide-1 analogue<br>|
| Placebo Comparator: Placebo<br>Placebo weekly sc injection | Biological: Placebo<br> <br> |
| Experimental: HM11260C 6 mg/week<br>HM11260C 6 mg weekly sc injection | Biological: HM11260C<br>* Glucagon-like peptide-1 analogue<br>|
| Experimental: HM11260C 6 mg/biweekly<br>HM11260C 6 mg biweekly sc injection | Biological: HM11260C<br>* Glucagon-like peptide-1 analogue<br>|
| Experimental: HM11260C 8 mg/biweekly<br>HM11260C 8 mg biweekly sc injection | Biological: HM11260C<br>* Glucagon-like peptide-1 analogue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight at 20 weeks |  | 20 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse event |  | during 20 weeks of treatment and follow-up period | 
| Change from baseline in HbA1c and fasting plasma glucose level at 20 week |  | 20 weeks from baseline | 
| Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week | Cholesterol level, LDL-C level | 20 weeks from baseline |