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Completed

NCT Number: NCT04779697

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 analogue - semaglutide

Drug

GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks

Other names: Semaglutide

Placebo

Other

Placebo - administered once weekly for a total of 12 weeks

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Food Intake - Real-World

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

    Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment.

  2. Change in Stress Score

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

    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.

Other outcomes

  1. Change in Weight

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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