Effect of LAPS-Exendin on Body Weight in Obese Population

NCT ID: NCT02075281

Last Updated: 2016-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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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

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Phase 2 study

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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HM11260C

HM11260C 4 mg weekly sc injection

Group Type EXPERIMENTAL

HM11260C

Intervention Type BIOLOGICAL

Glucagon-like peptide-1 analogue

Placebo

Placebo weekly sc injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

HM11260C 6 mg/week

HM11260C 6 mg weekly sc injection

Group Type EXPERIMENTAL

HM11260C

Intervention Type BIOLOGICAL

Glucagon-like peptide-1 analogue

HM11260C 6 mg/biweekly

HM11260C 6 mg biweekly sc injection

Group Type EXPERIMENTAL

HM11260C

Intervention Type BIOLOGICAL

Glucagon-like peptide-1 analogue

HM11260C 8 mg/biweekly

HM11260C 8 mg biweekly sc injection

Group Type EXPERIMENTAL

HM11260C

Intervention Type BIOLOGICAL

Glucagon-like peptide-1 analogue

Interventions

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HM11260C

Glucagon-like peptide-1 analogue

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hanmi pharmaceuticals Hanmi pharmaceuticals

Role: PRINCIPAL_INVESTIGATOR

Hanmi pharmaceuticals

Locations

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Hanmi pharmaceutical

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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HM-EXC-205

Identifier Type: -

Identifier Source: org_study_id

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