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

NCT04779697 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 20000278682R01DK099039-06
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Change in Craving Score

  Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment.

  Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0.

• Change in Hunger Score

  Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment.

  Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)

• Change in Food Intake

  Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment.

  Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change)

Secondary Outcomes (2)

• Change in Food Intake - Real-World

  Average change from baseline to end of treatment (Kcalories at week 12 - week 0)

• Change in Stress Score

  Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0)

Other Outcomes (1)

• Change in Weight

  Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0)

Study Arms (2)

GLP-1a

EXPERIMENTAL

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

Drug: GLP-1 analogue - semaglutide

Placebo

PLACEBO COMPARATOR

Placebo pen administered weekly over 12 weeks

Other: Placebo

Interventions

Placebo OTHER

Placebo - administered once weekly for a total of 12 weeks

Placebo

GLP-1 analogue - semaglutide DRUG

GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks

Also known as: Semaglutide

GLP-1a

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ania Jastreboff, MD, PhD
• Organization: Yale University / Yale School of Medicine

ania.jastreboff@yale.edu

203-737-1932

Study Officials

• Ania Jastreboff, MD, PhD

  Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology);

  PRINCIPAL INVESTIGATOR

• Rajita Sinha, PhD

  Psychiatry; Director Yale Stress Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 3, 2021
• Study Start: February 1, 2021
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Locations

US (1)