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

Yale University

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Other: Placebo; Drug: GLP-1 analogue - semaglutide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04779697

2000027868

2R01DK099039-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

GLP-1a

Experimental group

Description:

GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks

Treatment:

Drug: GLP-1 analogue - semaglutide

Placebo

Placebo Comparator group

Description:

Placebo pen administered weekly over 12 weeks

Treatment:

Other: Placebo