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OpenTrials
Completed

NCT Number: NCT02075281

Effect of LAPS-Exendin on Body Weight in Obese Population

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanmi pharmaceutical

Los Angeles, California, United States

About this study

Phase 2 study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

HM11260C

Biological

Glucagon-like peptide-1 analogue

Placebo

Biological

Primary outcomes

  1. Change from baseline in body weight at 20 weeks

    Time frame: 20 weeks from baseline

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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