← Trials/Trial dossier/NCT03374956

CompletedPhase 3Results posted

Individualized Obesity Pharmacotherapy

Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

Lead sponsor

Mayo Clinic

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

193

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Body weight, % change

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 IDNCT03374956
Org study ID17-003449

Timeline

Milestones

Study start2017-12-11actual
Study first posted2017-12-15actual
Primary completion2022-05-26actual
Study completion2022-05-26actual
Last update posted2023-07-18actual
Results first posted2023-07-18actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.

Exclusion criteria

Abdominal bariatric surgery
Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.
Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score >11 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.
Hypersensitivity to any of the study medications.
No contraindications to all FDA-approved medications

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.

Weight & body composition

6 endpoints
Primary/registry result

Change in Total Body Weight

Time frame:baseline to 12 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (median), percent change95% CI
Intervention Group-7.7-11 – -4.7
Control Group-6.5-11 – -2.3
Primary/protocol endpoint

Change in Total Body Weight

Time frame:baseline to 12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percentage of Responders

Time frame:baseline to 12 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Intervention Group81
Control Group80
Secondary/registry result

Percentage of Responders

Time frame:baseline to 12 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Intervention Group44
Control Group40
Secondary/protocol endpoint

Percentage of Responders

Time frame:baseline to 12 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Responders

Time frame:baseline to 12 weeks

≥10% weight-loss responders

threshold achievement, improvement

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 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.