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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects

Short name STABLE Wt Loss

NCTNCT05548647 (opens ClinicalTrials.gov in a new tab)Other id850370
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
120 participants (actual)
Sponsor
University of Pennsylvania · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
26 Jul 2022
Primary completion
12 May 2025
Completion
12 May 2025
First posted
21 Sept 2022
Last update posted
3 Aug 2026
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 4

    STABLE Wt Loss

    NCT05548647

    26 Jul 2022 to 12 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution) for 72 weeks.

Interventions

  • Behavioral TreatmentBehavioral
  • PlaceboDrug
  • Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]Drug

Arms2

  • Active comparator

    Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)

    Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60. At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).

  • Active comparator

    Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)

    Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the semaglutide-to-semaglutide group was not intended to be subject to statistical analysis. Therefore the week 72 results for this group represent those of the semaglutide-to-placebo group who took semaglutide for 60 weeks and then placebo for the last 12 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Study 1 Ad 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

    Registry description

    Primary outcome (Study 1)

  2. Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)

    Time frame · S2: Endpoint comparison at week 72

    Registry description

    Primary outcome (Study 2)

Secondary outcomes(14)

  1. Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).

  2. Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).

  3. Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.

  4. Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.

  5. Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.

  6. Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)

    Time frame · S1: Change from baseline to weeks 20, 40, and 60

    Registry description

    Secondary confirmatory outcome (Study 1): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.

  7. Study 1 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

    Registry description

    Secondary confirmatory outcome (Study 1): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.

  8. Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).

  9. Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).

  10. Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.

  11. Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.

  12. Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.

  13. Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.

  14. Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task

    Time frame · S2: Week 72 endpoint controlling for S1 baseline

    Registry description

    Secondary confirmatory outcome (Study 2): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)

GroupValue (kcal)Spread
Behavioral Treatment + Placebo (Weeks 0-60)-75.152.6
Behavioral Treatment + Medication (Weeks 0-60)-367.037.2
Secondary and other outcome results(7)
Secondary outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting

GroupValue (mm)Spread
Behavioral Treatment + Placebo (Weeks 0-60)3.82.6
Behavioral Treatment + Medication (Weeks 0-60)16.02.0
Secondary outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)

GroupValue (mm*min)Spread
Behavioral Treatment + Placebo (Weeks 0-60)1112.3665.2
Behavioral Treatment + Medication (Weeks 0-60)3309.3470.4
Secondary outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)

GroupValue (mm)Spread
Behavioral Treatment + Placebo (Weeks 0-60)-14.44.0
Behavioral Treatment + Medication (Weeks 0-60)-31.92.7
Secondary outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)

GroupValue (mm)Spread
Behavioral Treatment + Placebo (Weeks 0-60)8.93.7
Behavioral Treatment + Medication (Weeks 0-60)10.82.5
Other pre specified outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Body Weight (kg)

GroupValue (kg)Spread
Behavioral Treatment + Placebo (Weeks 0-60)-5.20.9
Behavioral Treatment + Medication (Weeks 0-60)-9.90.6
Other pre specified outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Craving Control Over the Past Week as Measured by the COEQ

GroupValue (mm)Spread
Behavioral Treatment + Placebo (Weeks 0-60)19.33.8
Behavioral Treatment + Medication (Weeks 0-60)32.22.8
Other pre specified outcomeMean· S1: Change from baseline to weeks 20, 40, and 60

Study 1 Craving for Savory Over the Past Week as Measured by the COEQ

GroupValue (mm)Spread
Behavioral Treatment + Placebo (Weeks 0-60)-18.53.7
Behavioral Treatment + Medication (Weeks 0-60)-29.92.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Behavioral Treatment + Placebo (Weeks 0-60)Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.0 / 480 / 4842 / 48
Behavioral Treatment + Medication (Weeks 0-60)Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.0 / 723 / 7270 / 72
Continuous Placebo (Weeks 60-72)At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).0 / 200 / 206 / 20
Medication (Semaglutide) Switched to Placebo (Weeks 60-72)Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to be switched to placebo at week 60. By re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis.0 / 430 / 4317 / 43
Continued Medication (Semaglutide) (Weeks 60-72)Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). Participants in this group are those assigned to continue semaglutide. By re-allocating a small number of subjects to Continued Medication at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the Continued Medication group was included only to maintain blinding and was not intended to be subject to statistical analysis. Because this group was very small, its characteristics are more likely have differed from other groups due to chance.0 / 100 / 103 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

9 results

Short- and long-term effects of semaglutide 2.4 mg on energy intake, appetite, and food reward: a 60-week, double-blind randomized controlled trial.

Tronieri et al. 2026The American journal of clinical nutrition

PMID 42323166PMC13494093DOI 10.1016/j.ajcnut.2026.101403PUB-42323166

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGordon K, Matthews A, Zeller MH, Lin J. Practical guidelines for eating disorder risk mitigation in patients undergoing obesity treatment for the pediatric provider. Curr Opin Pediatr. 2024 Aug 1;36(4):367-374. doi: 10.1097/MOP.0000000000001356. Epub 2024 Apr 5. PMID 38655793

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * non-pregnant, evidenced by a negative urine pregnancy test * non-lactating * surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study 5. Subjects must * Plan to remain in the Philadelphia area for the next 1.5 years. * Ability to provide informed consent before any trial-related activities. 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. 1\. To be eligible to participate in the re-randomized treatment period from weeks 60 to 72, subjects must also: * complete a week 60 assessment * be classified as "on drug" as at the week 60 assessment and report taking at least one dose of trial product within the past 2 weeks

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