Effect of LAPS-Exendin on Body Weight in Obese Population

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Biological: HM11260C; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02075281

HM-EXC-205

Details and patient eligibility

About

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.

Full description

Phase 2 study

Enrollment: 297 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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297 participants in 5 patient groups, including a placebo group

HM11260C

Experimental group

Description:

HM11260C 4 mg weekly sc injection

Treatment:

Biological: HM11260C

Placebo

Placebo Comparator group

Description:

Placebo weekly sc injection

Treatment:

Biological: Placebo

HM11260C 6 mg/week

Experimental group

Description:

HM11260C 6 mg weekly sc injection

Treatment:

Biological: HM11260C

HM11260C 6 mg/biweekly

Experimental group

Description:

HM11260C 6 mg biweekly sc injection

Treatment:

Biological: HM11260C

HM11260C 8 mg/biweekly

Experimental group

Description:

HM11260C 8 mg biweekly sc injection

Treatment:

Biological: HM11260C