Effect of LAPS-Exendin on Body Weight in Obese Population

NCT02075281 | Completed Phase 2

• 1 other identifier: HM-EXC-205
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in body weight at 20 weeks

  20 weeks from baseline

Secondary Outcomes (3)

• Number of participants with adverse event

  during 20 weeks of treatment and follow-up period

• Change from baseline in HbA1c and fasting plasma glucose level at 20 week

  20 weeks from baseline

• Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week

  20 weeks from baseline

Other Outcomes (2)

• Change from baseline in waist circumference at 20 week

  20 weeks after baseline

• Change from baseline in β-cell function at 20 week

  20 week from baseline

Study Arms (5)

HM11260C

EXPERIMENTAL

HM11260C 4 mg weekly sc injection

Biological: HM11260C

Placebo

PLACEBO COMPARATOR

Placebo weekly sc injection

Biological: Placebo

HM11260C 6 mg/week

EXPERIMENTAL

HM11260C 6 mg weekly sc injection

Biological: HM11260C

HM11260C 6 mg/biweekly

EXPERIMENTAL

HM11260C 6 mg biweekly sc injection

Biological: HM11260C

HM11260C 8 mg/biweekly

EXPERIMENTAL

HM11260C 8 mg biweekly sc injection

Biological: HM11260C

Interventions

HM11260C BIOLOGICAL

Glucagon-like peptide-1 analogue

HM11260C; HM11260C 6 mg/biweekly; HM11260C 6 mg/week; HM11260C 8 mg/biweekly

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi pharmaceutical

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Hanmi pharmaceuticals Hanmi pharmaceuticals

  Hanmi pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-02

Locations

US (1)