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Effect of LAPS-Exendin on Body Weight in Obese Population

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HM11260C
Placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

  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.

Sites / Locations

  • Hanmi pharmaceutical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

HM11260C

Placebo

HM11260C 6 mg/week

HM11260C 6 mg/biweekly

HM11260C 8 mg/biweekly

Arm Description

HM11260C 4 mg weekly sc injection

Placebo weekly sc injection

HM11260C 6 mg weekly sc injection

HM11260C 6 mg biweekly sc injection

HM11260C 8 mg biweekly sc injection

Outcomes

Primary Outcome Measures

Change from baseline in body weight at 20 weeks

Secondary Outcome Measures

Number of participants with adverse event
Change from baseline in HbA1c and fasting plasma glucose level at 20 week
Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week
Cholesterol level, LDL-C level

Full Information

First Posted
February 25, 2014
Last Updated
August 8, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02075281
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HM11260C
Arm Type
Experimental
Arm Description
HM11260C 4 mg weekly sc injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo weekly sc injection
Arm Title
HM11260C 6 mg/week
Arm Type
Experimental
Arm Description
HM11260C 6 mg weekly sc injection
Arm Title
HM11260C 6 mg/biweekly
Arm Type
Experimental
Arm Description
HM11260C 6 mg biweekly sc injection
Arm Title
HM11260C 8 mg/biweekly
Arm Type
Experimental
Arm Description
HM11260C 8 mg biweekly sc injection
Intervention Type
Biological
Intervention Name(s)
HM11260C
Intervention Description
Glucagon-like peptide-1 analogue
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in body weight at 20 weeks
Time Frame
20 weeks from baseline
Secondary Outcome Measure Information:
Title
Number of participants with adverse event
Time Frame
during 20 weeks of treatment and follow-up period
Title
Change from baseline in HbA1c and fasting plasma glucose level at 20 week
Time Frame
20 weeks from baseline
Title
Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week
Description
Cholesterol level, LDL-C level
Time Frame
20 weeks from baseline
Other Pre-specified Outcome Measures:
Title
Change from baseline in waist circumference at 20 week
Time Frame
20 weeks after baseline
Title
Change from baseline in β-cell function at 20 week
Description
homeostatic model assessment
Time Frame
20 week from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanmi pharmaceuticals Hanmi pharmaceuticals
Organizational Affiliation
Hanmi pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanmi pharmaceutical
City
Los angeles
State/Province
California
Country
United States

12. IPD Sharing Statement

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Effect of LAPS-Exendin on Body Weight in Obese Population

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