Clinical trial NCT04779697: GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
Official title: GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Craving
timeFrame: week 0 and week 12
measure: Change in Hunger
timeFrame: week 0 and week 12
measure: Change in Food Intake
timeFrame: week 0 and week 12
Secondary outcomes:
measure: Change in food intake - real-life
timeFrame: week 0, 4, 8, 12
measure: Change in stress
timeFrame: week 0, 4, 8, 12
Other outcomes:
measure: Change in weight
timeFrame: weekly for 12 weeks
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center: Yale University
state: Connecticut
Study officials:
affiliation: Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);
name: Ania Jastreboff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatry; Director Yale Stress Center
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: