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

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ClinicalTrials.gov Identifier: NCT04779697
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : December 15, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: GLP-1 analogue - semaglutide Other: Placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: GLP-1a
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
 Drug: GLP-1 analogue - semaglutide
GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
Other Name: Semaglutide
Placebo Comparator: Placebo
Placebo pen administered weekly over 12 weeks
 Other: Placebo
Placebo - administered once weekly for a total of 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Craving [ Time Frame: 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.

  2. Change in Hunger [ Time Frame: 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.

  3. Change in Food Intake [ Time Frame: week 0 and week 12 ]
    Food intake will be measured in KCalories during a validated observed laboratory task


Secondary Outcome Measures :
  1. Change in weight [ Time Frame: weekly for 12 weeks ]
    Weight in kilograms will be assessed using a bioimpedance scale

  2. Change in food intake - real-life [ Time Frame: week 0, 4, 8, 12 ]
    Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24)

  3. Change in stress [ Time Frame: week 0, 4, 8, 12 ]
    Stress, measured as total score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779697


Contacts
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Contact: Ania Jastreboff, MD, PhD (203) 737-5015 ania.jastreboff@yale.edu
Contact: Rajita Sinha, PhD (203) 737-1272 rajita.sinha@yale.edu

Locations
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United States, Connecticut
The Yale Stress Center: Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Seungju Hwang, BS    203-737-4011    seungju.hwang@yale.edu   
Contact: Ania Jastreboff, MD, PHD       ania.jastreboff@yale.edu   
Principal Investigator: Ania Jastreboff, MD, PhD         
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ania Jastreboff, MD, PhD Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);
Principal Investigator: Rajita Sinha, PhD Psychiatry; Director Yale Stress Center
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04779697    
Other Study ID Numbers: 2000027868
2R01DK099039-06 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes