GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT03523273

CompletedPhase 2Results posted

Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

Lead sponsor

Michael Camilleri, MD

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

136

actual

Study population

Obesity / overweight

Key I/E criterion

•Healthy volunteers

Primary endpoint

•Gastric Emptying of Solids (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 IDNCT03523273

Org study ID15-001783 Part B

Secondary IDR56DK067071

Secondary IDUL1TR000135

Timeline

Milestones

Study start2017-11-29actual

Study first posted2018-05-14actual

Primary completion2021-08-31actual

Study completion2021-08-31actual

Last update posted2022-06-23actual

Results first posted2022-06-23actual

Assets

Investigational agents

Liraglutide

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.

•The investigators plan to recruit equal proportions of men and women.

•Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. In addition, since liraglutide 3.0 mg is classified as Pregnancy Category X, monthly urine pregnancy testing will be performed in any female participant with childbearing potential.

•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, cholecystectomy, 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 past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels >500 mg/dL.

•Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), 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 HAD score >11 on either the Anxiety or Depression subscales, 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 any medication (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.

•Delayed gastric emptying at 2 and 4 hours

•Hypersensitivity to the study medication, liraglutide

•Participate in highly intense physical activity program that could potentially interfere with study interpretation.

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

Weight & body composition

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change in Weight at 5 Weeks

Time frame:baseline, 5 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (median), kilograms	95% CI
Liraglutide	-3.8	-4.8 – -2.5
Placebo	0.1	-1.5 – 1.4

p0.004Wilcoxon (Mann-Whitney)

Secondary/registry result

Change in Weight at 16 Weeks

Time frame:baseline, 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (median), kilograms	95% CI
Liraglutide	-5.8	-8.3 – -3.9
Placebo	0.0	-3.1 – 2.1

p0.033Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Change in Weight at 5 Weeks

Time frame:baseline, 5 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Weight 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 (T1/2)

Time frame:5 weeks

descriptive

Posted result

Group	Value (median), minutes	95% CI
Liraglutide	191.6	137.0 – 241.0
Placebo	105.9	92.6 – 127.8

Primary/registry result

Gastric Emptying of Solids (T1/2)

Time frame:16 weeks

descriptive

Posted result

Group	Value (median), minutes	95% CI
Liraglutide	154.4	120.4 – 178.3
Placebo	111.4	97.3 – 132.9

Primary/protocol endpoint

Gastric Emptying of Solids (T1/2)

Time frame:5 weeks

descriptive

Primary/protocol endpoint

Gastric Emptying of Solids (T1/2)

Time frame:16 weeks

descriptive

Secondary/registry result

Satiety

Time frame:16 weeks

descriptive

Posted result

Group	Value (median), kilocalories	95% CI
Liraglutide	647.5	472.4 – 826.4
Placebo	793.7	624.6 – 1019.3

Secondary/registry result

Satiation Volume to Fullness

Time frame:16 weeks

descriptive

Posted result

Group	Value (median), milliliters (mL)	95% CI
Liraglutide	622.1	496.7 – 746.6
Placebo	746.6	497.7 – 871.0

Secondary/registry result/low confidence

Maximum Satiation

Time frame:16 weeks

descriptive

Posted result

Group	Value (median), milliliters (mL)	95% CI
Liraglutide	974.4	746.6 – 1156.3
Placebo	1119.8	995.4 – 1430.9

Secondary/registry result

Fasting Gastric Volume Prior to Meal

Time frame:16 weeks

change from baseline, descriptive

Posted result

Group	Value (median), milliliters (mL)	95% CI
Liraglutide	221.2	187.7 – 269.8
Placebo	191.5	176.5 – 231.5

Secondary/registry result/low confidence

Gastric Volume After Meal

Time frame:16 weeks

descriptive

Posted result

Group	Value (median), milliliters (mL)	95% CI
Liraglutide	629.1	538.9 – 705.1
Placebo	583.8	549.8 – 667.7

Secondary/registry result

Gastric Accommodation

Time frame:16 weeks

change from baseline, descriptive

Posted result

Group	Value (median), milliliters (mL)	95% CI
Liraglutide	385.4	332.6 – 445.2
Placebo	391.8	348.6 – 433.5

Secondary/protocol endpoint/low confidence

Satiety

Time frame:16 weeks

descriptive, improvement

Secondary/protocol endpoint

Satiation Volume to Fullness

Time frame:16 weeks

descriptive

Secondary/protocol endpoint

Maximum Satiation

Time frame:16 weeks

descriptive

Secondary/protocol endpoint/low confidence

Gastric Accommodation

Time frame:16 weeks

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Fasting Gastric Volume Prior to Meal

Time frame:16 weeks

descriptive

Secondary/protocol endpoint/low confidence

Gastric Volume After Meal

Time frame:16 weeks

descriptive

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.