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Effect of LAPS-Exendin on Body Weight in Obese Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075281
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Biological: HM11260C Biological: Placebo Phase 2

Detailed Description:
Phase 2 study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: HM11260C
HM11260C 4 mg weekly sc injection
Biological: HM11260C
Glucagon-like peptide-1 analogue

Placebo Comparator: Placebo
Placebo weekly sc injection
Biological: Placebo
Experimental: HM11260C 6 mg/week
HM11260C 6 mg weekly sc injection
Biological: HM11260C
Glucagon-like peptide-1 analogue

Experimental: HM11260C 6 mg/biweekly
HM11260C 6 mg biweekly sc injection
Biological: HM11260C
Glucagon-like peptide-1 analogue

Experimental: HM11260C 8 mg/biweekly
HM11260C 8 mg biweekly sc injection
Biological: HM11260C
Glucagon-like peptide-1 analogue




Primary Outcome Measures :
  1. Change from baseline in body weight at 20 weeks [ Time Frame: 20 weeks from baseline ]

Secondary Outcome Measures :
  1. Number of participants with adverse event [ Time Frame: during 20 weeks of treatment and follow-up period ]
  2. Change from baseline in HbA1c and fasting plasma glucose level at 20 week [ Time Frame: 20 weeks from baseline ]
  3. Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week [ Time Frame: 20 weeks from baseline ]
    Cholesterol level, LDL-C level


Other Outcome Measures:
  1. Change from baseline in waist circumference at 20 week [ Time Frame: 20 weeks after baseline ]
  2. Change from baseline in β-cell function at 20 week [ Time Frame: 20 week from baseline ]
    homeostatic model assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075281


Locations
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United States, California
Hanmi pharmaceutical
Los angeles, California, United States
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Hanmi pharmaceuticals Hanmi pharmaceuticals Hanmi pharmaceuticals
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02075281    
Other Study ID Numbers: HM-EXC-205
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Body Weight