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CompletedPhase 2Results posted

Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity

Lead sponsor

Mayo Clinic

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

40

actual

Study population

Obesity / overweight

Key I/E criterion

Healthy volunteers

Primary endpoint

Gastric Emptying of Solids Half-time (T1/2)

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 IDNCT02647944
Org study ID15-001783

Timeline

Milestones

Study start2015-12-18actual
Study first posted2016-01-06estimated
Primary completion2016-12-30actual
Study completion2016-12-30actual
Last update posted2017-10-27actual
Results first posted2017-10-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Overweight and obese adults (≥30 kg/m^2 or ≥27 kg/m^2 with an obesity-related co-morbidity).
Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota.
Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders.
Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrolment and before each radiation exposure.
Subjects must have the ability to provide informed consent before any trial-related activities.

Exclusion criteria

Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).
Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat.
Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia-type 2.
Patients with a personal history of pancreatitis (acute or chronic)
Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory, a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety Depression (HAD) score >8 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers,Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia [which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation.
Hypersensitivity to the study medication, liraglutide.

Endpoints (20)

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

Other clinical outcomes
14
Weight & body composition
4
Other (unclassified)
2

Weight & body composition

4 endpoints
Secondary/registry result

Weight Change at 5 Weeks

Time frame:baseline, 5 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (median), kg95% CI
Liraglutide3.702.80 – 4.80
Placebo0.60-0.30 – 1.4
p<0.001Wilcoxon (Mann-Whitney)
Secondary/registry result

Weight Change at 16 Weeks

Time frame:baseline, 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (median), kg95% CI
Liraglutide5.305.20 – 6.80
Placebo2.50.1 – 4.2
p<0.001Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Weight Change at 5 Weeks

Time frame:baseline, 5 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Weight Change at 16 Weeks

Time frame:baseline, 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other clinical outcomes

14 endpoints
Primary/registry result

Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks

Time frame:5 weeks

descriptive

Posted result

GroupValue (median), minutes95% CI
Liraglutide180162 – 295
Placebo11796 – 137
Primary/registry result

Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks

Time frame:16 weeks

descriptive

Posted result

GroupValue (median), minutes95% CI
Liraglutide142120 – 177
Placebo113101 – 133
Primary/protocol endpoint/low confidence

Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks

Time frame:5 weeks

descriptive

Primary/protocol endpoint

Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks

Time frame:16 weeks

descriptive

Secondary/registry result

Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks

Time frame:16 weeks

descriptive, improvement

Posted result

GroupValue (median), kcal95% CI
Liraglutide554.0406 – 687
Placebo680.5513 – 1002
p0.27Wilcoxon (Mann-Whitney)
Secondary/registry result/low confidence

Satiation Volume to Fullness at 16 Weeks

Time frame:16 weeks

descriptive

Posted result

GroupValue (median), mL95% CI
Liraglutide360360 – 600
Placebo600480 – 720
p0.069Wilcoxon (Mann-Whitney)
Secondary/registry result/low confidence

Satiation Maximum Tolerated Volume at 16 Weeks

Time frame:16 weeks

descriptive

Posted result

GroupValue (median), mL95% CI
Liraglutide750651 – 908
Placebo1126944 – 1185
p0.054Wilcoxon (Mann-Whitney)
Secondary/registry result

Gastric Fasting Volume at 16 Weeks

Time frame:16 weeks

descriptive

Posted result

GroupValue (median), mL95% CI
Liraglutide231192 – 277
Placebo192179 – 223
p0.13Wilcoxon (Mann-Whitney)
Secondary/registry result

Gastric Postprandial Volume at 16 Weeks

Time frame:16 weeks

change from baseline, descriptive

Posted result

GroupValue (median), mL95% CI
Liraglutide705633 – 744
Placebo668605 – 794
p0.68Wilcoxon (Mann-Whitney)
Secondary/registry result

Gastric Accommodation Volume at 16 Weeks

Time frame:16 weeks (approximately 1 hour after 99mTC injection)

change from baseline, descriptive

Posted result

GroupValue (median), mL95% CI
Liraglutide453378 – 536
Placebo433408 – 602
p0.95Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint/low confidence

Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks

Time frame:16 weeks

descriptive, improvement

Secondary/protocol endpoint

Satiation Volume to Fullness at 16 Weeks

Time frame:16 weeks

descriptive

Secondary/protocol endpoint/low confidence

Satiation Maximum Tolerated Volume at 16 Weeks

Time frame:16 weeks

descriptive

Secondary/protocol endpoint

Gastric Accommodation Volume at 16 Weeks

Time frame:16 weeks (approximately 1 hour after 99mTC injection)

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint

Gastric Fasting Volume at 16 Weeks

Time frame:16 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Gastric Postprandial Volume at 16 Weeks

Time frame:16 weeks

descriptive

Publications (3)

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 tableClinicalTrials.gov results section

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.