Effect of LAPS-Exendin on Body Weight in Obese Population

August 8, 2016 updated by: Hanmi Pharmaceutical Company Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 2 study

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los angeles, California, United States
        • Hanmi pharmaceutical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body weight at 20 weeks
Time Frame: 20 weeks from baseline
20 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse event
Time Frame: during 20 weeks of treatment and follow-up period
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
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
20 weeks from baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in waist circumference at 20 week
Time Frame: 20 weeks after baseline
20 weeks after baseline
Change from baseline in β-cell function at 20 week
Time Frame: 20 week from baseline
homeostatic model assessment
20 week from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Hanmi pharmaceuticals Hanmi pharmaceuticals, Hanmi Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EXC-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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