Effect of LAPS-Exendin on Body Weight in Obese Population

Phase 2

Completed

• Conditions: Obesity
• Interventions: Biological: Placebo; Biological: HM11260C

• Registration Number: NCT02075281
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2016-02
• Disposition First Submitted: 2016-08-08
• Disposition First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Disposition First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo weekly sc injection
HM11260C 8 mg/biweekly	HM11260C	HM11260C 8 mg biweekly sc injection
HM11260C 6 mg/biweekly	HM11260C	HM11260C 6 mg biweekly sc injection
HM11260C	HM11260C	HM11260C 4 mg weekly sc injection
HM11260C 6 mg/week	HM11260C	HM11260C 6 mg weekly sc injection

Primary Outcome Measures

Name	Time	Method
Change from baseline in body weight at 20 weeks	20 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse event	during 20 weeks of treatment and follow-up period
Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week	20 weeks from baseline	Cholesterol level, LDL-C level
Change from baseline in HbA1c and fasting plasma glucose level at 20 week	20 weeks from baseline

Trial Locations

Locations (1)

Hanmi pharmaceutical; 🇺🇸 Los angeles, California, United States