← Trials/Trial dossier/NCT04779697

CompletedPhase 1Results posted

GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

Lead sponsor

Yale University

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

96

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 30-49.9

Primary endpoints

Craving ScoreHunger ScoreFood 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 IDNCT04779697
Org study ID2000027868
Secondary ID2R01DK099039-06

Timeline

Milestones

Study start2021-02-01actual
Study first posted2021-03-03actual
Primary completion2024-11-19actual
Study completion2024-11-19actual
Last update posted2026-02-10actual
Results first posted2026-02-10actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

BMI ranging from 30-49.9 kg/m2
No significant medical problems, including diabetes
No history of HgbA1c <6.5%
English speaking and able to read English and complete study evaluations
Able to provide informed written and verbal consent

Exclusion criteria

Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria
Meet current or past DSM-IVR criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications
Current active participation in a weight loss program or weight loss of >10% of total body weight during the prior 6 months
Taking any other anti-obesity medication
History of pancreatitis, medullary thyroid cancer, or MEN syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal

Endpoints (12)

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

Patient-reported / QoL
5
Other clinical outcomes
3
Weight & body composition
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Other/protocol endpoint

Change in Weight

Time frame:Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0)

Body weight, % change

percent change from baseline, improvement

Other_pre_specified/registry result

Change in Weight

Time frame:Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0)

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
GLP-1a-4.53
Placebo-0.17
p< 0.001ANOVA

Patient-reported / QoL

5 endpoints
Primary/registry result

Change in Hunger Score

Time frame:Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)

change from baseline, improvement

Posted result

GroupValue (mean), score95% CI
GLP-1a-0.5
Placebo-0.1
p> 0.27ANOVA
Primary/protocol endpoint

Change in Craving Score

Time frame:Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0.

change from baseline, improvement

Primary/protocol endpoint

Change in Hunger Score

Time frame:Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)

change from baseline, improvement

Secondary/registry result

Change in Stress Score

Time frame:Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

change from baseline, improvement

Posted result

GroupValue (mean), score95% CI
GLP-1a-2.8
Placebo-1.7
p> 0.53ANOVA
Secondary/protocol endpoint

Change in Stress Score

Time frame:Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/registry result/low confidence

Change in Craving Score

Time frame:Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0.

change from baseline, improvement

Posted result

GroupValue (mean), score95% CI
GLP-1a-0.7
Placebo-0.3
p< 0.001ANOVA
Primary/registry result

Change in Food Intake

Time frame:Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change)

change from baseline, improvement

Posted result

GroupValue (mean), Kcalories95% CI
GLP-1a-0.4
Placebo0.4
p< 0.043ANOVA
Primary/protocol endpoint

Change in Food Intake

Time frame:Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change)

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/registry result/low confidence

Change in Food Intake - Real-World

Time frame:Average change from baseline to end of treatment (Kcalories at week 12 - week 0)

change from baseline, improvement

Posted result

GroupValue (mean), Kcalories95% CI
GLP-1a-485.7
Placebo-124.5
p< 0.015ANOVA
Secondary/protocol endpoint/low confidence

Change in Food Intake - Real-World

Time frame:Average change from baseline to end of treatment (Kcalories at week 12 - week 0)

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.