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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: GLP-1 analogue - semaglutide
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1a<br>GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks | Drug: GLP-1 analogue - semaglutide<br>* GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks<br>* Other names: Semaglutide;|
| Placebo Comparator: Placebo<br>Placebo pen administered weekly over 12 weeks | Other: Placebo<br>* Placebo - administered once weekly for a total of 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Craving | Craving will be measured using a validated questionnaire called Food Craving Scale (FCS). FCS is an 28-item questionnaire that measures how often participates experienced a craving for a food type. Participants can respond to each item from never to always/ almost every. HIgher scores indicate greater craving. | week 0 and week 12 | 
| Change in Hunger | Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 9. Higher VAS indicates greater hunger. | week 0 and week 12 | 
| Change in Food Intake | Food intake will be measured in KCalories during a validated observed laboratory task | week 0 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight in kilograms will be assessed using a bioimpedance scale | weekly for 12 weeks | 
| Change in food intake - real-life | Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24) | week 0, 4, 8, 12 | 
| Change in stress | Stress, measured as total score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. | week 0, 4, 8, 12 |