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History of Changes for Study: NCT02075281
Effect of LAPS-Exendin on Body Weight in Obese Population
Latest version (submitted August 8, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 27, 2014 None (earliest Version on record)
2 February 18, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 August 8, 2016 Study Status
Comparison Format:

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Study NCT02075281
Submitted Date:  February 27, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: HM-EXC-205
Brief Title: Effect of LAPS-Exendin on Body Weight in Obese Population
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Not yet recruiting
Study Start: February 2014
Primary Completion: February 2016 [Anticipated]
Study Completion: February 2016 [Anticipated]
First Submitted: February 25, 2014
First Submitted that
Met QC Criteria:
February 27, 2014
First Posted: March 3, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 27, 2014
Last Update Posted: March 3, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hanmi Pharmaceutical Company Limited
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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
Open or close this module Conditions
Conditions: Obesity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Hanmi Pharmaceutical Hanmi pharmaceutical
Telephone: clinicl4@hanmi.co.kr
Email: clinicl4@hanmi.co.kr
Central Contact Backup: Hanmi Pharmaceutical Hanmi pharmaceutical
Email: clinicl4@hanmi.co.kr
Study Officials: Hanmi pharmaceuticals Hanmi pharmaceuticals
Principal Investigator
Hanmi pharmaceuticals
Locations: United States, California
Hanmi pharmaceutical
Los angeles, California, United States
Contact:Contact: Hanmi pharmaceutical Hanmi pharmaceutical clinicl4@hanmi.co.kr
Contact:Principal Investigator: Hanmi pharmaceutical Hanmi pharmaceutical
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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