Status:
COMPLETED
GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 processe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04779697
Start Date
February 1 2021
End Date
November 19 2024
Last Update
February 12 2025
Active Locations (1)
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1
The Yale Stress Center: Yale University
New Haven, Connecticut, United States, 06519