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Active not recruiting

CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

Enrollment

7

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Food Craving Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06467604
Org study ID2184712

Timeline

Milestones

Study first posted2024-06-21actual
Study start2024-11-01actual
Last update posted2026-04-15actual
Primary completion2027-03-12estimated
Study completion2027-04-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

The study includes male and female participants aged 18 to under 70 years diagnosed with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, sleep apnea, cardiovascular disease). They must have a history of at least one unsuccessful dietary effort to lose weight and be on a stable medication regimen affecting weight or diabetes outcomes for at least three months. Short courses of antibiotics and steroids are allowed. Participants must have maintained a stable weight (±5%) over the past three months, be under physician care, provide food diary data, have a smartphone or tablet for a food logging app, communicate in English, and provide informed consent.

Inclusion criteria

1. Male or female, age 18.0-<70 years

2. Obese (BMI greater than or equal to 30.0 kg/m2) or overweight (BMI greater than or equal to 27.0 kg/m2) with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease and history of at least one self-reported unsuccessful dietary effort to lose body weight will be recruited.

3. On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)

4. Weight stable (+/- 5%) over previous 3 months

5. Be under the care of a physician who will be responsible for managing participant's treatment regimen

6. Willingness to provide food diary data throughout trial

7. Access to a smartphone/tablet that can download the food logging application

8. Willing and able to provide a valid email address for use in the study

9. Be able to communicate (oral and written) in English

10. Be able to provide informed consent

Exclusion criteria

1. History of weight loss surgery

2. History of major surgery within three months of enrollment

3. Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening

4. Use of systemic hormonal therapies (contraceptive medication is allowed)

5. History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed)

6. Hemoglobinopathy that interferes with measurement of HbA1c

7. Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening

8. Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation

9. Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues

10. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

11. Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases

12. Diagnosis or strong clinical suspicion of eating disorders

13. Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years

14. Lifetime history of a suicide attempt

15. History of gastroparesis or other gut dysmotility syndrome

16. Prior use of other GLP-1RA or combination GIP/GLP-1RA medications or previous participation in any GLP-1RA trials

17. Pregnant or lactating women, women planning to become pregnant in the next 12 months

18. Multiple patient-reported food allergies/intolerances significantly limiting food intake

19. Smoking, illicit drug use, vaporizer and/or electronic cigarette use

20. Currently consuming >14 alcoholic drinks per week

21. Extreme dietary or exercise patterns

22. Individuals who are not yet adults (infants, children, teenagers)

23. Individuals who are currently incarcerated or serving a prison sentence

24. Individuals unable to provide informed consent due to factors such as mental incapacity or language barriers

25. Any disorder, inability, or unwillingness to comply with the study protocol that may jeopardize patient safety or compliance, based on the investigator's opinion

Pregnancy and Other Exclusions during Trial:

1. If a patient experiences a pregnancy, her data will be censored from the time of estimated conception, and she will be excluded from further participation.

2. If a patient develops active cancer (except skin cancer), they will be excluded from further participation due to safety concerns/contraindications for weight loss.

3. If a patient develops another exclusionary condition, such as unstable angina or another condition for which weight loss or exercise might be contraindicated, further participation will be determined by the Medical Monitoring Team (PI, Project Manager).

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
7
Patient-reported / QoL
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

7 endpoints
Other/protocol endpoint

Changes in weight in kilograms

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Changes in waist circumference (cm)

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Change in weight loss percentage

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Changes in body fat percentage

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Changes in skeletal muscle mass (lbs)

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Lean mass

change from baseline, improvement

Other/protocol endpoint

Changes in visceral fat mass (L)

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Visceral fat, change

change from baseline, improvement

Other/protocol endpoint

Changes in segmental skeletal muscle mass (lbs)

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Lean mass

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Primary/protocol endpoint

Change in Food Craving Score

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Change in USDA Healthy Eating Index-2015 (HEI) Score

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Changes in resting metabolic rate (RMR)

Time frame:Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.