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STABLE Wt Loss
CompletedPhase 4Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects
Short- and Long-term Effects of Once Weekly Semaglutide 2.4 mg on Appetite, Eating Behavior, and Psychosocial Status
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
120
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Ad libitum energy intake (kcal) during a buffet lunch meal
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Men and women who report a desire to lose weight
2. Aged 18-70 years
3. Body mass index [BMI] ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with an obesity-related comorbidity (e.g., treated or untreated hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)
4. Eligible female patients will be:
5. Subjects must
Exclusion criteria
1. A diagnosis of type I or II diabetes
2. Hemoglobin A1c (HbA1c) > 6.5%
3. Uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg)
4. Clinically significant hepatic (i.e., liver fibrosis, cirrhosis or confirmed NASH) or renal disease
5. Uncontrolled thyroid disease
6. Experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 6 months, congestive heart failure, or heart block greater than first degree
7. A history of acute pancreatitis in the last 6 months
8. Any history of chronic pancreatitis
9. A history of malignancy (other than non-melanoma skin cancer) within the last 5 years
10. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
11. A self-reported change in body weight >5kg (11 lbs) within 90 days before screening
12. Used within the last 6 months medications known to produce weight loss/gain (e.g., medications approved for weight loss, oral steroids, antipsychotic medications) or any GLP-1 receptor agonist.
13. Known or suspected allergy or hypersensitivity to trial medication(s), excipients, or related products
14. The receipt of any investigational drug within 6 months prior to this trial
15. Applicants with current severe major depressive disorder (BDI-II score ≥ 29 or Patient Health Questionnaire-9 [PHQ-9] score > 15) or severe anxiety disorder
16. Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year (such individuals will be referred for psychiatric treatment if they have not previously received it).
17. Any severity of psychotic or bipolar disorder
18. Bulimia nervosa diagnosis within the past 5 years
19. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
20. History of (or plans to receive in the next 1.5 years) bariatric surgery or a weight loss device. (However, the following will be allowed: liposuction or abdominoplasty > 1 year before screening, laparoscopic banding if removed > 1 year before screening, intragastric balloon or aspire assist if removed > 1 year before screening.)
21. Inability to walk 5 blocks or more (comfortably) or engage in another form of aerobic activity.
22. Women who are nursing, pregnant, or planning to become pregnant in the next 1.5 years or are not using adequate contraceptive measures
23. Previous participation in this trial (e.g., randomized but failed to participate)
24. Changes to any chronic medication (type or dosage) within the past 3 months.
25. Food allergy or dietary preference that would prevent the individual from consuming the standard breakfast or ad libitum lunch.
Endpoints (19)
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
1 endpointBody weight (kg)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
Body weight, absolute change (kg)
change from baseline, improvement
Patient-reported / QoL
12 endpointsLaboratory-based appetite measured as a composite of visual analogue scale ratings (hunger, fullness, satiety, prospective consumption) when fasting and after eating (area under the curve). This is a single outcome calculated by combining the VAS ratings
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
componentshunger vas, fullness vas, satiety vas, prospective consumption vas
Global subjective appetite (e.g., hunger, fullness, food preoccupation) over the past week measured using the Control of Eating Questionnaire (COEQ)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Food cravings over the past week as measured by the COEQ (Three factors: craving control, craving for sweet foods, craving for savory foods)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Food cravings as measured by the General Food Cravings Questionnaire - Trait
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Eating behavior including cognitive restraint and dietary disinhibition (Eating Inventory)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Weight-related self-efficacy (WEL-short form)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Mood as assessed using the PHQ-9
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Drive for thinness (Eating Disorder Inventory [EDI])
Time frame:Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Ratings of food palatability and of nausea, thirst, and wellbeing fasting and in the 4 hours after consuming the standard breakfast meal
Time frame:S1: Change from baseline to weeks 20, 40, and 60, and measures at week 72; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Body image satisfaction (Body Satisfaction Scale)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Weight-related self stigmatization by the Weight Bias Internalization Scale
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Other clinical outcomes
6 endpointsAd libitum energy intake (kcal) during a buffet lunch meal (4 hrs after standardized breakfast)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Explicit food liking measured during the Leeds Food Preference Task
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Symptoms of disordered eating including clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) as assessed by the Eating Disorder Examination (EDE)
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Self-reported loss-of-control eating (Loss of Control Eating Scale [LOCES])
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Food addiction measured by Yale Food Addiction Scale
Time frame:S1: Change from baseline to weeks 20, 40, and 60; S2: Week 72 endpoint controlling for S1 baseline
change from baseline, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Current opinion in pediatrics2024 Aug 1PMID38655793doi:10.1097/MOP.0000000000001356via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.