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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

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE March 3, 2014
Last Update Posted Date August 9, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Change from baseline in body weight at 20 weeks [ Time Frame: 20 weeks from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • Number of participants with adverse event [ Time Frame: during 20 weeks of treatment and follow-up period ]
  • Change from baseline in HbA1c and fasting plasma glucose level at 20 week [ Time Frame: 20 weeks from baseline ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 27, 2014)
  • Change from baseline in waist circumference at 20 week [ Time Frame: 20 weeks after baseline ]
  • Change from baseline in β-cell function at 20 week [ Time Frame: 20 week from baseline ]
    homeostatic model assessment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of LAPS-Exendin on Body Weight in Obese Population
Official Title  ICMJE 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
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.
Detailed Description Phase 2 study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Biological: HM11260C
    Glucagon-like peptide-1 analogue
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: HM11260C
    HM11260C 4 mg weekly sc injection
    Intervention: Biological: HM11260C
  • Placebo Comparator: Placebo
    Placebo weekly sc injection
    Intervention: Biological: Placebo
  • Experimental: HM11260C 6 mg/week
    HM11260C 6 mg weekly sc injection
    Intervention: Biological: HM11260C
  • Experimental: HM11260C 6 mg/biweekly
    HM11260C 6 mg biweekly sc injection
    Intervention: Biological: HM11260C
  • Experimental: HM11260C 8 mg/biweekly
    HM11260C 8 mg biweekly sc injection
    Intervention: Biological: HM11260C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2016)
297
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2014)
300
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02075281
Other Study ID Numbers  ICMJE HM-EXC-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hanmi Pharmaceutical Company Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hanmi Pharmaceutical Company Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hanmi pharmaceuticals Hanmi pharmaceuticals Hanmi pharmaceuticals
PRS Account Hanmi Pharmaceutical Company Limited
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP