GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects

A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS

Lead sponsor

Pfizer

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-40

Primary endpoint

•Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches

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 IDNCT03041792

Org study IDA9001498

Timeline

Milestones

Study first posted2017-02-03estimated

Study start2017-02-20actual

Primary completion2018-01-16actual

Study completion2018-01-16actual

Last update posted2019-07-26actual

Results first posted2019-07-26actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males and female subjects;

•Body Mass Index 30-40 kg/m2;

Exclusion criteria

•Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Endpoints (18)

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

Safety / tolerability / PK

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
LiraglutideVisit 4	4.52	—
Visit 5	4.13	—
PlaceboVisit 4	-0.60	—
Visit 5	-0.99	—

Least Square Mean Difference4.9595% CI0.61 – 9.29p0.0263Mixed Models Analysis

Visit 4

Least Square Mean Difference5.3595% CI1.22 – 9.48p0.0121Mixed Models Analysis

Visit 5

Secondary/registry result/low confidence

Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

componentssatiety vas auc, fullness vas auc, hunger vas auc, prospective food consumption vas auc

Posted result

Group	Value (mean), units on a scale	95% CI
LiraglutideSatiety (Visit 4)	3.94	—
Satiety (Visit 5)	4.51	—
Fullness (Visit 4)	4.04	—
Fullness (Visit 5)	2.40	—
Prospective food consumption (Visit 4)	-7.74	—
Prospective food consumption (Visit 5)	-6.18	—
Hunger (Visit 4)	-3.71	—
Hunger (Visit 5)	-3.41	—
PlaceboSatiety (Visit 4)	-0.55	—
Satiety (Visit 5)	1.02	—
Fullness (Visit 4)	1.88	—
Fullness (Visit 5)	1.89	—
Prospective food consumption (Visit 4)	1.59	—
Prospective food consumption (Visit 5)	4.23	—
Hunger (Visit 4)	2.13	—
Hunger (Visit 5)	2.63	—

Least Square Mean Difference3.9895% CI-1.85 – 9.82p0.1768Mixed Models Analysis

Satiety (Visit 4)

Least Square Mean Difference3.4395% CI-0.85 – 7.70p0.1137Mixed Models Analysis

Satiety (Visit 5)

Least Square Mean Difference2.8595% CI-1.41 – 7.11p0.1858Mixed Models Analysis

Fullness (Visit 4)

Least Square Mean Difference1.4195% CI-3.05 – 5.86p0.5288Mixed Models Analysis

Fullness (Visit 5)

Least Square Mean Difference-8.4695% CI-14.30 – -2.61p0.0054Mixed Models Analysis

Prospective food consumption (Visit 4)

Least Square Mean Difference-9.7895% CI-17.29 – -2.27p0.0117Mixed Models Analysis

Prospective food consumption (Visit 5)

Least Square Mean Difference-6.5895% CI-11.48 – -1.69p0.0093Mixed Models Analysis

Hunger (Visit 4)

Least Square Mean Difference-6.3995% CI-12.12 – -0.66p0.0296Mixed Models Analysis

Hunger (Visit 5)

Secondary/protocol endpoint

Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

Safety / tolerability / PK

10 endpoints

Secondary/registry result

Number of Participants With Vital Signs Data Meeting Categorical Criteria

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Value (count_of_participants), Participants	95% CI
LiraglutideSupine DBP <50 mmHg	3	—
Supine PR <40 bpm	0	—
Supine PR >120 bpm	0	—
Supine SBP <90 mmHg	1	—
Increase in supine DBP >=20 mmHg	3	—
Increase in supine SBP >=30 mmHg	1	—
Decrease in supine DBP >=20 mmHg	3	—
Decrease in supine SBP >=30 mmHg	1	—
PlaceboSupine DBP <50 mmHg	5	—
Supine PR <40 bpm	0	—
Supine PR >120 bpm	0	—
Supine SBP <90 mmHg	2	—
Increase in supine DBP >=20 mmHg	1	—
Increase in supine SBP >=30 mmHg	1	—
Decrease in supine DBP >=20 mmHg	9	—
Decrease in supine SBP >=30 mmHg	0	—

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (All-Causality)

Time frame:Baseline (Visit 3) up to 31 days post last dose (75 days)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide	31	—
Placebo	20	—

Secondary/registry result

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
LiraglutidePR interval >=300 milliseconds (msec)	0	—
QRS interval >=200 msec	0	—
QTcF >450 - <=480 msec	2	—
QTcF >480 - <=500 msec	0	—
QTcF >500 msec	0	—
PR interval percent increase >=25/50%	0	—
QRS interval percent increase >=25/50%	0	—
QTcF increase >30 - <=60 msec	2	—
QTcF increase >60 msec	0	—
PlaceboPR interval >=300 milliseconds (msec)	0	—
QRS interval >=200 msec	0	—
QTcF >450 - <=480 msec	2	—
QTcF >480 - <=500 msec	0	—
QTcF >500 msec	0	—
PR interval percent increase >=25/50%	0	—
QRS interval percent increase >=25/50%	0	—
QTcF increase >30 - <=60 msec	1	—
QTcF increase >60 msec	0	—

Secondary/registry result

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide	32	—
Placebo	26	—

Secondary/registry result

Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5

Time frame:Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), microgramminute/milliliter (ugmin/mL)	95% CI
LiraglutideAUC0-60min (Visit 4)	18.30	—
AUC0-60min (Visit 5)	81.19	—
AUC0-300min (Visit 4)	197.79	—
AUC0-300min (Visit 5)	394.22	—
PlaceboAUC0-60min (Visit 4)	-4.55	—
AUC0-60min (Visit 5)	-8.28	—
AUC0-300min (Visit 4)	-12.92	—
AUC0-300min (Visit 5)	47.31	—

Least Square Mean Difference35.5695% CI-69.64 – 140.76p0.5008Mixed Models Analysis

AUC0-60min (Visit 4)

Least Square Mean Difference106.1595% CI7.86 – 204.44p0.0348Mixed Models Analysis

AUC0-60min (Visit 5)

Least Square Mean Difference214.2495% CI-45.59 – 474.07p0.1040Mixed Models Analysis

AUC0-300min (Visit 4)

Least Square Mean Difference348.4395% CI70.20 – 626.66p0.0152Mixed Models Analysis

AUC0-300min (Visit 5)

Secondary/protocol endpoint

Number of Participants With Vital Signs Data Meeting Categorical Criteria

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (All-Causality)

Time frame:Baseline (Visit 3) up to 31 days post last dose (75 days)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Time frame:Baseline (Visit 3) up to Visit 6 (Study Day 53)

event count, event

Secondary/protocol endpoint

Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5

Time frame:Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)

AUC₀–∞

change from baseline, descriptive

Other clinical outcomes

3 endpoints

Primary/registry result

Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5

Time frame:Visit 3, Visit 4 and Visit 5

change from baseline, improvement

Posted result

Group	Value (mean), kilocalories (kcal)	95% CI
LiraglutideVisit 4	-254.48	—
Visit 5	-278.78	—
PlaceboVisit 4	-19.93	—
Visit 5	-37.43	—

Least Square Mean Difference-235.7595% CI-322.25 – -149.25p0.0000Mixed Models Analysis

Visit 4

Least Square Mean Difference-243.6395% CI-339.10 – -148.15p0.0000Mixed Models Analysis

Visit 5

Primary/protocol endpoint

Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5

Time frame:Visit 3, Visit 4 and Visit 5

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

Posted result

Group	Value (mean), kcal	95% CI
LiraglutideVisit 4	-1058.8	—
Visit 5	-1152.5	—
PlaceboVisit 4	-205.64	—
Visit 5	-242.84	—

Least Square Mean Difference-859.5895% CI-1196.1 – -523.10p0.0000Mixed Models Analysis

Visit 4

Least Square Mean Difference-928.5695% CI-1317.3 – -539.86p0.0000Mixed Models Analysis

Visit 5

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5

Time frame:Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

change from baseline, improvement

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.