DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04311411

CompletedPhase 1Results posted

A Study of Tirzepatide in Overweight and Very Overweight Participants

Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI

Assets

Liraglutide / Tirzepatide

Listed sites

3

Recruiting sites

—

Enrollment

114

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-50

Primary endpoint

•Calorie Intake

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 IDNCT04311411
Org study ID17223
Secondary IDI8F-MC-GPHHEli Lilly and Company

Timeline

Milestones

Study first posted2020-03-17actual
Study start2020-08-24actual
Primary completion2022-12-16actual
Study completion2022-12-16actual
Last update posted2024-05-22actual
Results first posted2024-05-22actual

Assets

Investigational agents

LiraglutideTirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have stable body weight for the past 1 month prior to screening
•Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening
•Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
•Women must not be pregnant or breastfeeding

Exclusion criteria

•Have undergone or plan to undergo gastric bypass or bariatric surgery
•Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements
•Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
•Unwilling to comply with smoking and alcohol restrictions during the study
•Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
•Have a diagnosis of type 2 diabetes

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

Other (unclassified)
4
Patient-reported / QoL
2

Patient-reported / QoL

2 endpoints
Secondary/registry result

Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score

Time frame:Baseline, Week 3

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
PlaceboFasting (Pre-lunch)2.15—
Postprandial (Post-lunch)-0.59—
TirzepatideFasting (Pre-lunch)22.72—
Postprandial (Post-lunch)1.66—
LiraglutideFasting (Pre-lunch)8.78—
Postprandial (Post-lunch)0.05—
Mean Difference (Final Values)20.5795% CI12.11 – 29.02p<.0001Mixed Models Analysis

Fasting (Pre-lunch)

Mean Difference (Final Values)6.6395% CI-1.53 – 14.79p0.1097Mixed Models Analysis

Fasting (Pre-lunch)

Mean Difference (Final Values)13.9495% CI5.49 – 22.38p0.0015Mixed Models Analysis

Fasting (Pre-lunch)

Mean Difference (Final Values)2.2595% CI-3.60 – 8.09p0.4469Mixed Models Analysis

Postprandial (Post-lunch)

Mean Difference (Final Values)0.6495% CI-5.02 – 6.31p0.8227Mixed Models Analysis

Postprandial (Post-lunch)

Mean Difference (Final Values)1.6195% CI-4.23 – 7.45p0.5861Mixed Models Analysis

Postprandial (Post-lunch)

Secondary/protocol endpoint

Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score

Time frame:Baseline, Week 3

change from baseline, improvement

Other (unclassified)

4 endpoints
Primary/registry result/low confidence

Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3

Time frame:Baseline, Week 3

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kilocalories (kcal)95% CI
Placebo10.95—
Tirzepatide-523.15—
Median Difference (Final Values)-534.1195% CI-668.20 – -400.02p<.0001ANCOVA
Primary/protocol endpoint/low confidence

Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3

Time frame:Baseline, Week 3

change from baseline, descriptive

Secondary/registry result/low confidence

Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas

Time frame:Baseline, Week 3

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), Arbitrary Units95% CI
PlaceboInsula-0.0739—
Medial frontal gyrus0.0504—
Superior temporal gyrus0.0132—
Precentral gyrus0.0441—
Cingulate gyrus0.0283—
TirzepatideInsula-0.0301—
Medial frontal gyrus0.0494—
Superior temporal gyrus0.0174—
Precentral gyrus0.0249—
Cingulate gyrus0.0214—
LiraglutideInsula0.0190—
Medial frontal gyrus0.0581—
Superior temporal gyrus0.0621—
Precentral gyrus0.0845—
Cingulate gyrus0.0967—
Median Difference (Final Values)0.043995% CI-0.0994 – 0.1871p0.5437Mixed Models Analysis

Insula

Mean Difference (Final Values)0.093095% CI-0.0441 – 0.2301p0.1806Mixed Models Analysis

Insula

Mean Difference (Final Values)-0.049195% CI-0.1846 – 0.0863p0.4720Mixed Models Analysis

Insula

Mean Difference (Final Values)-0.001195% CI-0.1079 – 0.1058p0.9842Mixed Models Analysis

Medial frontal gyrus

Mean Difference (Final Values)0.007795% CI-0.0949 – 0.1102p0.8822Mixed Models Analysis

Medial frontal gyrus

Mean Difference (Final Values)-0.008795% CI-0.1111 – 0.0937p0.8657Mixed Models Analysis

Medial frontal gyrus

Mean Difference (Final Values)0.004395% CI-0.1650 – 0.1736p0.9599Mixed Models Analysis

Superior temporal gyrus

Mean Difference (Final Values)0.048995% CI-0.1129 – 0.2107p0.5490Mixed Models Analysis

Superior temporal gyrus

Mean Difference (Final Values)-0.044695% CI-0.2068 – 0.1176p0.5854Mixed Models Analysis

Superior temporal gyrus

Mean Difference (Final Values)-0.019295% CI-0.1259 – 0.0874p0.7203Mixed Models Analysis

Precentral gyrus

Mean Difference (Final Values)0.040495% CI-0.0617 – 0.1425p0.4330Mixed Models Analysis

Precentral gyrus

Mean Difference (Final Values)-0.059695% CI-0.1619 – 0.0426p0.2488Mixed Models Analysis

Precentral gyrus

Mean Difference (Final Values)-0.007095% CI-0.1059 – 0.0919p0.8886Mixed Models Analysis

Cingulate gyrus

Mean Difference (Final Values)0.068495% CI-0.0267 – 0.1635p0.1563Mixed Models Analysis

Cingulate gyrus

Mean Difference (Final Values)-0.075495% CI-0.1704 – 0.0196p0.1182Mixed Models Analysis

Cingulate gyrus

Secondary/protocol endpoint/low confidence

Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas

Time frame:Baseline, Week 3

change from baseline, descriptive

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.