Effect of LAPS-Exendin on Body Weight in Obese Population

Conditions

Obesity

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

Richard E Pratley, Stephan Jacob, Seungjae Baek, Michael E Trautmann, Marcus Hompesch et al. (10 authors)

BMJ Open Diabetes Research & Care2022-01-0112 citations

10.1136/bmjdrc-2021-002207

1001-P: Effects of Efpeglenatide on Body Weight, BMI, and Waist Circumference in Patients With Obesity Without Diabetes Stratified by Baseline Characteristics: A Subanalysis of BALANCE 205

Richard E. Pratley, Stephan Jacob, Jahoon Kang, Michael Trautmann, Marcus Hompesch et al. (10 authors)

Diabetes2019-06-01

10.2337/db19-1001-p

53-OR: Efficacy of Efpeglenatide in Patients with Obesity and Prediabetes: A Subanalysis of the BALANCE 205 Study

Richard E. Pratley, Stephan Jacob, Jahoon Kang, Michael Trautmann, Marcus Hompesch et al. (10 authors)

Diabetes2019-06-01

10.2337/db19-53-or

Interventions

BIOLOGICALHM11260C

Glucagon-like peptide-1 analogue

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in body weight at 20 weeks	20 weeks from baseline

Secondary

Measure	Time frame	Description
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	Cholesterol level, LDL-C level

Other

Measure	Time frame	Description
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	homeostatic model assessment

Countries

United States

Outcome results

None listed