Trial Outcomes & Findings for GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight (NCT NCT04779697)
NCT ID: NCT04779697
Last Updated: 2026-02-10
Results Overview
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.
COMPLETED
PHASE1
96 participants
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.
2026-02-10
Participant Flow
Participant milestones
| Measure |
GLP-1a
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
Placebo
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
Total
n=86 Participants
Total of all reporting groups
|
GLP-1a
n=43 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 8.7 • n=1581 Participants
|
36.3 years
STANDARD_DEVIATION 9.0 • n=4626 Participants
|
36.6 years
STANDARD_DEVIATION 9.4 • n=41 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=1581 Participants
|
62 Participants
n=4626 Participants
|
30 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
13 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
12 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
31 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=1581 Participants
|
55 Participants
n=4626 Participants
|
26 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
5 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=1581 Participants
|
86 participants
n=4626 Participants
|
43 participants
n=41 Participants
|
|
Years of Education
|
16.4 years
STANDARD_DEVIATION 2.7 • n=1581 Participants
|
16.3 years
STANDARD_DEVIATION 2.5 • n=4626 Participants
|
16.1 years
STANDARD_DEVIATION 2.3 • n=41 Participants
|
|
Regularly Use Substances
Yes
|
13 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
21 Participants
n=41 Participants
|
|
Regularly Use Substances
No
|
30 Participants
n=1581 Participants
|
52 Participants
n=4626 Participants
|
22 Participants
n=41 Participants
|
|
Baseline Body Mass Index (BMI)
|
36.9 kg/m^2
STANDARD_DEVIATION 4.2 • n=1581 Participants
|
37.1 kg/m^2
STANDARD_DEVIATION 4.3 • n=4626 Participants
|
37.3 kg/m^2
STANDARD_DEVIATION 4.5 • n=41 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=43 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Craving Score
|
-0.3 score
Standard Deviation 0.4
|
-0.7 score
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)Population: Data presented here is for all participants that completed the assessment.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=40 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Hunger Score
|
-0.1 score
Standard Deviation 1.7
|
-0.5 score
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 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)Population: Data presented here is for all participants that completed the assessment.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=40 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Food Intake
|
0.4 Kcalories
Standard Deviation 2.4
|
-0.4 Kcalories
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Average change from baseline to end of treatment (Kcalories at week 12 - week 0)Population: Data presented here is from all participants that completed the assessment.
Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=38 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Food Intake - Real-World
|
-124.5 Kcalories
Standard Deviation 583.5
|
-485.7 Kcalories
Standard Deviation 657.6
|
SECONDARY outcome
Timeframe: Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)Population: Data presented here is from all participants that completed the assessment.
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=36 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Stress Score
|
-1.7 score
Standard Deviation 8.1
|
-2.8 score
Standard Deviation 7.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0)Percent change in Weight in kilograms will be assessed using a bioimpedance scale. higher negative score indicates greater change with treatment.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
GLP-1a
n=43 Participants
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Change in Weight
|
-0.17 percent change
Standard Deviation 4.01
|
-4.53 percent change
Standard Deviation 4.59
|
Adverse Events
GLP-1a
Placebo
Serious adverse events
| Measure |
GLP-1a
n=48 participants at risk
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
Placebo
n=48 participants at risk
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
General disorders
Chest Pain
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
Other adverse events
| Measure |
GLP-1a
n=48 participants at risk
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
|
Placebo
n=48 participants at risk
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
31.2%
15/48 • Number of events 31 • 12 weeks
|
20.8%
10/48 • Number of events 10 • 12 weeks
|
|
Gastrointestinal disorders
Bloating/Gas
|
10.4%
5/48 • Number of events 12 • 12 weeks
|
6.2%
3/48 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Constipation/Hard Stools
|
18.8%
9/48 • Number of events 11 • 12 weeks
|
6.2%
3/48 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
29.2%
14/48 • Number of events 26 • 12 weeks
|
10.4%
5/48 • Number of events 10 • 12 weeks
|
|
Gastrointestinal disorders
Gastroesophogeal Reflux
|
18.8%
9/48 • Number of events 17 • 12 weeks
|
2.1%
1/48 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Lack/Loss of Appetite
|
12.5%
6/48 • Number of events 8 • 12 weeks
|
6.2%
3/48 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
58.3%
28/48 • Number of events 75 • 12 weeks
|
20.8%
10/48 • Number of events 15 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
13/48 • Number of events 28 • 12 weeks
|
4.2%
2/48 • Number of events 2 • 12 weeks
|
|
General disorders
Chills
|
10.4%
5/48 • Number of events 5 • 12 weeks
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
|
General disorders
Fatigue
|
14.6%
7/48 • Number of events 9 • 12 weeks
|
6.2%
3/48 • Number of events 3 • 12 weeks
|
|
General disorders
Fever
|
10.4%
5/48 • Number of events 5 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
General disorders
Injection Site Reaction
|
10.4%
5/48 • Number of events 5 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
8.3%
4/48 • Number of events 12 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
4/48 • Number of events 4 • 12 weeks
|
4.2%
2/48 • Number of events 2 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
8.3%
4/48 • Number of events 9 • 12 weeks
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Headache/Migraine
|
29.2%
14/48 • Number of events 26 • 12 weeks
|
18.8%
9/48 • Number of events 16 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
3/48 • Number of events 4 • 12 weeks
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat/Throat Infection
|
8.3%
4/48 • Number of events 4 • 12 weeks
|
4.2%
2/48 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
3/48 • Number of events 3 • 12 weeks
|
8.3%
4/48 • Number of events 4 • 12 weeks
|
Additional Information
Ania Jastreboff, MD, PhD
Yale University / Yale School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place