Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT04779697Other id2000027868Other id2R01DK099039-06

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 96 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 1 Feb 2021
Primary completion: 19 Nov 2024
Completion: 19 Nov 2024
First posted: 3 Mar 2021
Last update posted: 10 Feb 2026
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 1
GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
NCT04779697
1 Feb 2021 to 19 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GLP-1 analogue - semaglutideDrug
PlaceboOther

Arms2

Experimental
GLP-1a
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
Placebo comparator
Placebo
Placebo pen administered weekly over 12 weeks

Primary outcomes3

Outcomes the sponsor listed as primary.

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.
Registry description
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)
Registry description
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)
Registry description
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.

Secondary outcomes(2)

Change in Food Intake - Real-World
Time frame · Average change from baseline to end of treatment (Kcalories at week 12 - week 0)
Registry description
Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment.
Change in Stress Score
Time frame · Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

Group	Value (score)	Spread
GLP-1a	-0.7	0.6
Placebo	-0.3	0.4

Primary outcomeMean· Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)

Change in Hunger Score

Group	Value (score)	Spread
GLP-1a	-0.5	1.7
Placebo	-0.1	1.7

Primary outcomeMean· 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 in Food Intake

Group	Value (Kcalories)	Spread
GLP-1a	-0.4	1.8
Placebo	0.4	2.4

Secondary and other outcome results(3)

Secondary outcomeMean· Average change from baseline to end of treatment (Kcalories at week 12 - week 0)

Change in Food Intake - Real-World

Group	Value (Kcalories)	Spread
GLP-1a	-485.7	657.6
Placebo	-124.5	583.5

Secondary outcomeMean· Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

Change in Stress Score

Group	Value (score)	Spread
GLP-1a	-2.8	7.2
Placebo	-1.7	8.1

Other pre specified outcomeMean· Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0)

Change in Weight

Group	Value (percent change)	Spread
GLP-1a	-4.53	4.59
Placebo	-0.17	4.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GLP-1aGLP-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	0 / 48	1 / 48	39 / 48
PlaceboPlacebo pen administered weekly over 12 weeks Placebo: Placebo - administered once weekly for a total of 12 weeks	0 / 48	0 / 48	32 / 48

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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