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

Phase 1

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: GLP-1 analogue - semaglutide; Other: Placebo

• Registration Number: NCT04779697
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
GLP-1a	GLP-1 analogue - semaglutide	GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
Placebo	Placebo	Placebo pen administered weekly over 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in Craving	week 0 and week 12	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.
Change in Food Intake	week 0 and week 12	Food intake will be measured in KCalories during a validated observed laboratory task
Change in Hunger	week 0 and week 12	Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 9. Higher VAS indicates greater hunger.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Yale Stress Center: Yale University; 🇺🇸 New Haven, Connecticut, United States