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CompletedPhase 2

Effect of LAPS-Exendin on Body Weight in Obese Population

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

Assets

Efpeglenatide / Exenatide

Listed sites

1

Recruiting sites

Enrollment

297

actual

Study population

Obesity / overweight

Key I/E criterion

Healthy volunteers

Primary endpoint

Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02075281
Org study IDHM-EXC-205

Timeline

Milestones

Study first posted2014-03-03estimated
Last update posted2016-08-09estimated
Study start2014-02 (month precision)
Primary completion2015-01actual (month precision)
Study completion2015-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Eligibility 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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
2
Glycemic / diabetes
2
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Change from baseline in body weight at 20 weeks

Time frame:20 weeks from baseline

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change from baseline in waist circumference at 20 week

Time frame:20 weeks after baseline

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

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

Time frame:20 weeks from baseline

change from baseline, improvement

componentsHbA1c, change, Fasting glucose, change

Other/protocol endpoint

Change from baseline in β-cell function at 20 week

Time frame:20 week from baseline

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

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

Time frame:20 weeks from baseline

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with adverse event

Time frame:during 20 weeks of treatment and follow-up period

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.