ObesityPhase 1NCT04779697

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

A Phase 1 study testing GLP-1 analogue - semaglutide in people with Obesity, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Obesity
What is being tested?: GLP-1 analogue - semaglutide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 19 Nov 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Yale Stress Center: Yale University
New Haven, Connecticut, 06519

Other trials in United States

About this study

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

Read the detailed description

A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.

Conditions: Obesity
Being tested: GLP-1 analogue - semaglutide, Placebo
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLP-1 analogue - semaglutideDrug
Also called Semaglutide
GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
PlaceboOther
Placebo - administered once weekly for a total of 12 weeks

Study groups in NCT04779697
Study group	Role	What they receive
GLP-1a	Experimental	GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks Receives: Drug: GLP-1 analogue - semaglutide
Placebo	Placebo comparator	Placebo pen administered weekly over 12 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Craving Score
Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment.
Measured: 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 in Hunger Score
Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment.
Measured: Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)
Change in Food Intake
Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment.
Measured: 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)

Secondary outcomes (2)

Change in Food Intake - Real-World
Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment.
Measured: Average change from baseline to end of treatment (Kcalories at week 12 - week 0)
Change in Stress Score
Stress, measured as total summed score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. A negative change indicates lower stress with treatment. The Perceived Stress Scale (PSS)-14 has a total score range of 0 to 56, with individual items scored from 0 ("Never") to 4 ("Very often") and positively worded items reverse-scored before summing.
Measured: Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202119 Nov 2024

First posted3 Mar 2021
Study start1 Feb 2021
Primary completion19 Nov 2024
Study completion19 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04779697
Sponsor's protocol ID: 2000027868
Other IDs: 2R01DK099039-06
Status last verified: Jan 2026
First submitted: 10 Feb 2021
Last updated: 10 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
ClinicalTrials.gov ID: NCT04779697
Acronym / sponsor ID: 2000027868
Conditions: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 1 Feb 2021 (actual)
Primary completion: 19 Nov 2024 (actual)
Study completion: 19 Nov 2024 (actual)
First posted: 3 Mar 2021 (actual)
Results: Posted 10 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GLP-1a	Experimental	Drug: GLP-1 analogue - semaglutideGLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
Placebo	Placebo comparator	Other: PlaceboPlacebo pen administered weekly over 12 weeks

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLP-1 analogue - semaglutideAlso: SemaglutideGLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks	Drug	GLP-1a
PlaceboPlacebo - administered once weekly for a total of 12 weeks	Other	Placebo

Primary outcome

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 in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment.
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)
Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment.
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)
Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment.

2 secondary outcomes

Change in Food Intake - Real-World
Time frame: Average change from baseline to end of treatment (Kcalories at week 12 - week 0)
Change in Stress Score
Time frame: Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GLP-1a	48	43
Placebo	48	43

Primary outcome: 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.. Mean (Standard Deviation). Unit: score

Measure	GLP-1a n = 43	Placebo n = 43
Value	-0.7 (0.6)	-0.3 (0.4)

GLP-1a vs Placebo: p < 0.001, ANOVA

Primary outcome: 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). Mean (Standard Deviation). Unit: score

Measure	GLP-1a n = 40	Placebo n = 38
Value	-0.5 (1.7)	-0.1 (1.7)

GLP-1a vs Placebo: p > 0.27, ANOVA

Population analysed: Data presented here is for all participants that completed the assessment.

Primary outcome: 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). Mean (Standard Deviation). Unit: Kcalories

Measure	GLP-1a n = 40	Placebo n = 38
Value	-0.4 (1.8)	0.4 (2.4)

GLP-1a vs Placebo: p < 0.043, ANOVA

Population analysed: Data presented here is for all participants that completed the assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GLP-1a	1 of 48 (2.1%)	39 of 48 (81.3%)	0 of 48
Placebo	0 of 48 (0%)	32 of 48 (66.7%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ania Jastreboff, MD, PhD principal investigator

Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);

Rajita Sinha, PhD principal investigator

Psychiatry; Director Yale Stress Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLP-1 analogue - semaglutide in people with Obesity, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04779697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.