Effect of LAPS-Exendin on Body Weight in Obese Population

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075281
• Other study ID #: HM-EXC-205
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2014
• Last updated: August 8, 2016
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Phase 2 study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Biological:
• HM11260C
Glucagon-like peptide-1 analogue
• Placebo

Locations

Country	Name	City	State
United States	Hanmi pharmaceutical	Los angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in waist circumference at 20 week		20 weeks after baseline	No
Other	Change from baseline in ß-cell function at 20 week	homeostatic model assessment	20 week from baseline	No
Primary	Change from baseline in body weight at 20 weeks		20 weeks from baseline	No
Secondary	Number of participants with adverse event		during 20 weeks of treatment and follow-up period	Yes
Secondary	Change from baseline in HbA1c and fasting plasma glucose level at 20 week		20 weeks from baseline	No
Secondary	Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week	Cholesterol level, LDL-C level	20 weeks from baseline	No