Effect of LAPS-Exendin on Body Weight in Obese Population
NCT ID: NCT02075281
Last Updated: 2016-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
297 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HM11260C
HM11260C 4 mg weekly sc injection
HM11260C
Glucagon-like peptide-1 analogue
Placebo
Placebo weekly sc injection
Placebo
HM11260C 6 mg/week
HM11260C 6 mg weekly sc injection
HM11260C
Glucagon-like peptide-1 analogue
HM11260C 6 mg/biweekly
HM11260C 6 mg biweekly sc injection
HM11260C
Glucagon-like peptide-1 analogue
HM11260C 8 mg/biweekly
HM11260C 8 mg biweekly sc injection
HM11260C
Glucagon-like peptide-1 analogue
Interventions
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HM11260C
Glucagon-like peptide-1 analogue
Placebo
Eligibility Criteria
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Inclusion Criteria
* Genders: male and female
* healthy obese population
* non-diabetes
* stable body weight for at least 3 months prior to screening
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmi pharmaceuticals Hanmi pharmaceuticals
Role: PRINCIPAL_INVESTIGATOR
Hanmi pharmaceuticals
Locations
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Hanmi pharmaceutical
Los Angeles, California, United States
Countries
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Other Identifiers
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HM-EXC-205
Identifier Type: -
Identifier Source: org_study_id
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