A Phase 4 interventional study of Behavioral Treatment and Placebo in Obesity, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
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.
This trial consists of a single 72-week treatment period during which two studies will be conducted. Study 1 (i.e., long-term treatment trial; weeks 0-60) is a 60-week, single center, double-blinded, randomized controlled, parallel group design trial, and Study 2 (i.e., re-randomized medication withdrawal trial; weeks 60-72) is a separate, 12-week, double-blind, re-randomized medication withdrawal trial.
The long-term treatment trial (Study 1) will randomly assign (in a 3:2 semaglutide:placebo ratio) 120 subjects with a body mass index (BMI) ≥30 kg/m2, or ≥27 kg/m2 with ≥1 obesity-related co-morbidities, to 60 weeks of: 1) placebo with moderate intensity lifestyle intervention (as used in STEP 1); or 2) semaglutide 2.4 mg with the same lifestyle intervention. All subjects will receive 60 weeks of trial product, which will be up-titrated over 16 weeks in those assigned to semaglutide 2.4 mg. They will complete assessments of energy intake, appetite, food reward, mood, symptoms of disordered eating, and anthropomorphic measurements at baseline (week 0) and weeks 20, 40, and 60.
The primary aim in the initial long-term treatment trial will be to compare the long-term effect of semaglutide 2.4 mg vs placebo on ad libitum energy intake during a lunch meal at weeks 20, 40, and 60. Confirmatory secondary aims will test the effect of semaglutide 2.4 mg at weeks 20, 40 and 60 on subjective appetite ratings (both measured during a standardized breakfast in the lab and as experienced more globally over the past week), explicit food reward, as measured with the Power of Food Scale (24), and implicit food reward, as measured with the Leeds Food Preference Task (25, 26). Measures of food cravings, mood, eating disorder symptoms, and self-report measures of eating behavior will be considered supportive secondary endpoints and will provide additional evidence of the medication's safety and efficacy.
Following the completion of Study 1 at week 60, all subjects who complete a week 60 assessment and remain on drug will be enrolled in Study 2. Semaglutide-treated subjects will be re-randomized (in a 1:4 semaglutide:placebo ratio) to receive semaglutide 2.4 mg or placebo for 12 weeks. All subjects originally assigned to placebo will continue with that medication for an additional 12 weeks. Both researchers and subjects will remain blinded to subjects' original and re-randomized (or continued) treatment assignments. The goal of this re-randomized medication withdrawal period will be to compare the 80% of subjects originally assigned to semaglutide 2.4 mg who receive placebo at week 60 (semaglutide-to-placebo group) to the subjects originally randomized to placebo (continuous-placebo group) on all primary and secondary outcome measures at week 72 (after controlling for Study 1 baseline/week 0 values). All subjects will terminate trial product at cumulative week 72 and will return to clinic for a final safety visit at week 76.
Outcome assessments including ad libitum energy intake, subjective measures of appetite, food reward, eating behavior, mood, and eating disorder symptoms will occur at weeks 0, 20, 40, and 60 of Study 1 and at week 12 (72 weeks from original randomization) of the re-randomized treatment period. Measurements of body weight, waist circumference, blood pressure, pulse, and global, past-week appetite and food cravings (COEQ) also will be collected every 4 weeks throughout both treatment studies.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible female patients will be:
Subjects must
Exclusion Criteria:
1. To be eligible to participate in the re-randomized treatment period from weeks 60 to 72, subjects must also:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Behavioral Treatment · Drug: Placebo
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.
Behavioral: Behavioral Treatment · Drug: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
All participants, regardless of medication assignment, will receive the same 60-week behavioral weight loss program. Brief (15-minute), individual lifestyle counseling sessions will be delivered by a psychologist, behavioral health counselor, or registered dietitian (or other trained health care provider) at weeks 0 (i.e., baseline/randomization), 2, 4 and every fourth week from week 4 to week 60 (17 sessions) of Study 1. Subjects will be instructed to consume a self-selected diet of 1200-1500 kcal/day (for those who weigh \< 250 lb) or 1500-1800 kcal/day (for those who weigh ≥250 lb). They will be instructed to engage in low-to-moderate intensity physical activity (e.g., walking), gradually building to a goal of ≥150 minutes per week (spread across 5 days) by week 40. They will be instructed to use calorie counting and self-monitoring to meet their goals.
Also known as: Lifestyle modification, Behavioral weight loss, Lifestyle intervention
An inactive saline solution administered via subcutaneous injection
Also known as: Placebo for medication
Drug page: Semaglutide
Semaglutide 2.4 mg is a once weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist that has been FDA approved for weight loss
Also known as: Wegovy
Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Primary outcome (Study 1)
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Primary outcome (Study 2)
Time frame: S2: Endpoint comparison at week 72
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
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).
Time frame: 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)
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).
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
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.
Time frame: 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)
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.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
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.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
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.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
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.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
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).
Time frame: S2: Week 72 endpoint controlling for S1 baseline
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)
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).
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
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.
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
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.
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
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.
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
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.
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
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.
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Study 1 Body Weight (kg)
Supportive secondary outcome (Study 1): Body weight change (kg)
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving Control Over the Past Week as Measured by the COEQ
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving control (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater ability to control food cravings.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving for Savory Over the Past Week as Measured by the COEQ
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for savory foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for savory foods.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for sweet foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for sweet foods.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait
Supportive secondary outcome (Study 1): Food cravings as measured by the General Food Cravings Questionnaire - Trait (G-FCQ-T 21-item). Score range 21-126, higher scores indicate more/stronger food cravings.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Explicit Liking of High-fat Savory Foods (LFPT)
Supportive secondary outcome (Study 1) Explicit liking of high-fat savory foods as measured on 100-mm VAS scales (mean of high-fat savory items) during the Leeds Food Preference Task. Score range 0 - 100 mm with higher scores indicating greater liking of high-fat savory foods.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Cognitive Restraint (Eating Inventory)
Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Disinhibition (Eating Inventory)
Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Weight-related Self-efficacy
Supportive secondary outcome (Study 1) Mean score on the Weight-related self-efficacy (WEL-short form). Sum of 8 items, score range 0-80, higher scores indicate greater weight-related self-efficacy.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Mood as Assessed Using the PHQ-9
Supportive secondary outcome (Study 1): Depressed mood as assessed using the PHQ-9. Score range 0 - 27; higher scores indicate more symptoms of depressed mood.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)
Supportive secondary outcome (Study 1): Clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) in the past 12 weeks as assessed by the Eating Disorder Examination (EDE). Score is the count of binge episodes, range ≥0, more episodes indicates more frequent binge eating in the past 12 weeks.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)
Supportive secondary outcome (Study 1): Self-reported loss-of-control eating as measured by the Loss of Control Eating Scale (LOCES). Mean score range 1-5; higher scores indicate greater/more frequent loss of control over eating.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale
Exploratory outcome (Study 1): Food addiction symptoms measured by Yale Food Addiction Scale (YFAS). Symptom number range 0-11, higher scores indicate more food addiction symptoms
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])
Supportive secondary outcome (Study 1): Study 1 Drive for thinness as measured by the Eating Disorder Inventory (EDI). Score range 0-28; higher scores indicate greater drive for thinness.
Time frame: Change from baseline to weeks 20, 40, and 60
Study 1 Ratings of Nausea When Fasting
Exploratory outcome (Study 1): Ratings of nausea using 100 mm visual analogue scales when fasting in the laboratory prior to consuming the standard breakfast meal. Score range 0-100 mm; higher scores indicate greater nausea.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Ratings of Food Palatability
Exploratory outcome (Study 1): Ratings of food palatability using 100 mm visual analogue scales during a laboratory test meal. Score range 0-100 mm; higher scores indicate higher liking of the food taste.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)
Exploratory outcome (Study 1): Body image dissatisfaction (Body Satisfaction Scale). Mean of 13 items, score range 1-7, higher scores indicate greater body part dissatisfaction.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 1 Weight-related Self Stigmatization
Exploratory outcome (Study 1): Weight-related self stigmatization by the Weight Bias Internalization Scale. Mean of 11 items; score range 1-7; higher scores indicate greater weight-related self-stigmatization.
Time frame: S1: Change from baseline to weeks 20, 40, and 60
Study 2 Body Weight (kg)
Supportive secondary outcome (Study 2): Body weight (kg) at week 72
Time frame: S2: Week 72 endpoint controlling for S1 baseline
Participants were recruited between July 2022 and February 2024 via print and social media advertisements.
| Milestone | Behavioral Treatment + Placebo (Weeks 0-60) // Continuous Placebo (Weeks 60-72) | Behavioral Treatment + Medication (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) // Switched to Placebo (Weeks 60-72) | Behavioral Treatment + Medication (Weeks 0-60) // Continuous Medication (Weeks 60-72) |
|---|---|---|---|---|
| Started | 48 | 72 | 0 | 0 |
| Week 20 | 37 | 70 | 0 | 0 |
| Week 40 | 27 | 62 | 0 | 0 |
| Completed | 26 | 61 | 0 | 0 |
| Not completed | 22 | 11 | 0 | 0 |
| Milestone | Behavioral Treatment + Placebo (Weeks 0-60) // Continuous Placebo (Weeks 60-72) | Behavioral Treatment + Medication (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) // Switched to Placebo (Weeks 60-72) | Behavioral Treatment + Medication (Weeks 0-60) // Continuous Medication (Weeks 60-72) |
|---|---|---|---|---|
| Started | 20 | 0 | 43 | 10 |
| Completed | 18 | 0 | 41 | 9 |
| Not completed | 2 | 0 | 2 | 1 |
Primary outcome (Study 1)
| kcal | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -75.1 ± 52.6 | -367.0 ± 37.2 |
| Week 40 | -76.8 ± 73.8 | -317.0 ± 49.7 |
| Week 60 | 69.6 ± 73.9 | -200.0 ± 50.1 |
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).
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 3.8 ± 2.6 | 16.0 ± 2.0 |
| Week 40 | -0.5 ± 3.6 | 6.9 ± 2.4 |
| Week 60 | 1.4 ± 3.6 | 2.3 ± 2.4 |
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).
| mm*min | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 1112.3 ± 665.2 | 3309.3 ± 470.4 |
| Week 40 | 645.5 ± 1125.5 | 2595.1 ± 608.8 |
| Week 60 | 712.5 ± 1050.4 | 2065.8 ± 650.7 |
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.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -14.4 ± 4.0 | -31.9 ± 2.7 |
| Week 40 | -14.6 ± 5.0 | -25.4 ± 3.2 |
| Week 60 | -10.6 ± 4.4 | -17.4 ± 3.0 |
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.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 8.9 ± 3.7 | 10.8 ± 2.5 |
| Week 40 | 8.2 ± 4.4 | 4.9 ± 2.9 |
| Week 60 | 5.9 ± 4.1 | 4.3 ± 2.8 |
Supportive secondary outcome (Study 1): Body weight change (kg)
| kg | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -5.2 ± 0.9 | -9.9 ± 0.6 |
| Week 40 | -6.0 ± 1.4 | -15.0 ± 1.0 |
| Week 60 | -3.6 ± 1.9 | -15.4 ± 1.4 |
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving control (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater ability to control food cravings.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 19.3 ± 3.8 | 32.2 ± 2.8 |
| Week 40 | 15.8 ± 4.1 | 30.2 ± 2.7 |
| Week 60 | 14.7 ± 4.6 | 27.1 ± 3.2 |
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for savory foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for savory foods.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -18.5 ± 3.7 | -29.9 ± 2.6 |
| Week 40 | -16.6 ± 4.0 | -27.1 ± 2.6 |
| Week 60 | -14.9 ± 4.4 | -19.8 ± 2.8 |
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for sweet foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for sweet foods.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -17.5 ± 3.9 | -23.0 ± 2.8 |
| Week 40 | -17.5 ± 3.9 | -15.8 ± 2.9 |
| Week 60 | -15.0 ± 4.2 | -11.7 ± 3.0 |
Supportive secondary outcome (Study 1): Food cravings as measured by the General Food Cravings Questionnaire - Trait (G-FCQ-T 21-item). Score range 21-126, higher scores indicate more/stronger food cravings.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -11.0 ± 2.6 | -18.4 ± 1.8 |
| Week 40 | -8.8 ± 2.9 | -20.2 ± 1.9 |
| Week 60 | -9.7 ± 3.6 | -18.6 ± 2.3 |
Supportive secondary outcome (Study 1) Explicit liking of high-fat savory foods as measured on 100-mm VAS scales (mean of high-fat savory items) during the Leeds Food Preference Task. Score range 0 - 100 mm with higher scores indicating greater liking of high-fat savory foods.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -5.1 ± 4.0 | -15.4 ± 2.5 |
| Week 40 | -2.2 ± 5.5 | -10.3 ± 3.3 |
| Week 60 | -7.0 ± 4.8 | -9.8 ± 3.2 |
Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 3.8 ± 0.6 | 4.5 ± 0.4 |
| Week 40 | 3.5 ± 0.7 | 4.0 ± 0.5 |
| Week 60 | 2.3 ± 0.5 | 3.2 ± 0.4 |
Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -1.4 ± 0.5 | -3.3 ± 0.3 |
| Week 40 | -1.3 ± 0.6 | -3.8 ± 0.4 |
| Week 60 | -1.6 ± 0.6 | -3.5 ± 0.4 |
Supportive secondary outcome (Study 1) Mean score on the Weight-related self-efficacy (WEL-short form). Sum of 8 items, score range 0-80, higher scores indicate greater weight-related self-efficacy.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 10.3 ± 2.6 | 14.5 ± 1.9 |
| Week 40 | 8.6 ± 3.5 | 16.6 ± 2.3 |
| Week 60 | 3.9 ± 3.9 | 14.5 ± 2.7 |
Supportive secondary outcome (Study 1): Depressed mood as assessed using the PHQ-9. Score range 0 - 27; higher scores indicate more symptoms of depressed mood.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -1.2 ± 0.6 | -1.0 ± 0.4 |
| Week 40 | -2.0 ± 0.6 | -1.6 ± 0.4 |
| Week 60 | -1.4 ± 0.8 | -2.0 ± 0.5 |
Supportive secondary outcome (Study 1): Clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) in the past 12 weeks as assessed by the Eating Disorder Examination (EDE). Score is the count of binge episodes, range ≥0, more episodes indicates more frequent binge eating in the past 12 weeks.
| Binge episodes | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -4.2 ± 2.3 | -4.9 ± 1.3 |
| Week 40 | -3.9 ± 2.3 | -5.0 ± 1.3 |
| Week 60 | -3.7 ± 2.4 | -4.9 ± 1.3 |
Supportive secondary outcome (Study 1): Self-reported loss-of-control eating as measured by the Loss of Control Eating Scale (LOCES). Mean score range 1-5; higher scores indicate greater/more frequent loss of control over eating.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -0.5 ± 0.1 | -0.8 ± 0.1 |
| Week 40 | -0.5 ± 0.1 | -0.9 ± 0.1 |
| Week 60 | -0.6 ± 0.1 | -0.8 ± 0.1 |
Exploratory outcome (Study 1): Food addiction symptoms measured by Yale Food Addiction Scale (YFAS). Symptom number range 0-11, higher scores indicate more food addiction symptoms
| Number of symptoms | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -1.3 ± 0.4 | -1.6 ± 0.3 |
| Week 40 | -1.8 ± 0.4 | -1.9 ± 0.2 |
| Week 60 | -1.8 ± 0.4 | -2.1 ± 0.3 |
Supportive secondary outcome (Study 1): Study 1 Drive for thinness as measured by the Eating Disorder Inventory (EDI). Score range 0-28; higher scores indicate greater drive for thinness.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 0.2 ± 0.8 | -1.9 ± 0.6 |
| Week 40 | 0.6 ± 0.9 | -2.6 ± 0.7 |
| Week 60 | -1.1 ± 0.9 | -3.8 ± 0.6 |
Primary outcome (Study 2)
| kcal | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast) | 1073.0 ± 71.1 | 951.8 ± 42.9 | 657.7 ± 81.5 |
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.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -14.7 ± 3.7 | -29.6 ± 2.6 |
| Week 40 | -17.0 ± 4.1 | -24.9 ± 2.7 |
| Week 60 | -13.1 ± 3.6 | -22.4 ± 2.6 |
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.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -0.55 ± 0.13 | -0.98 ± 0.09 |
| Week 40 | -0.51 ± 0.15 | -1.10 ± 0.09 |
| Week 60 | -0.67 ± 0.18 | -1.01 ± 0.12 |
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.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -3.7 ± 4.1 | -5.9 ± 2.7 |
| Week 40 | 4.7 ± 4.7 | -0.6 ± 2.9 |
| Week 60 | 2.6 ± 5.1 | -1.9 ± 3.4 |
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).
| mm | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting | 33.7 ± 3.8 | 32.7 ± 2.3 | 47.7 ± 5.3 |
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).
| mm*min | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| 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) | 14354 ± 997 | 14533 ± 668 | 16914 ± 1292 |
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.
| mm | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ) | 48.5 ± 5.2 | 63.6 ± 3.5 | 38.5 ± 7.7 |
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.
| mm | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ) | 57.4 ± 5.0 | 59.4 ± 3.5 | 76.7 ± 6.9 |
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.
| mm | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ) | 42.7 ± 5.0 | 62.9 ± 3.5 | 26.4 ± 7.4 |
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.
| Units on a scale | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version) | 2.1 ± 0.2 | 2.5 ± 0.1 | 1.7 ± 0.3 |
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.
| Units on a scale | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task | 4.6 ± 4.8 | -7.2 ± 3.0 | -2.9 ± 8.7 |
Exploratory outcome (Study 1): Ratings of nausea using 100 mm visual analogue scales when fasting in the laboratory prior to consuming the standard breakfast meal. Score range 0-100 mm; higher scores indicate greater nausea.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | 0.8 ± 4.3 | 7.6 ± 3.0 |
| Week 40 | -0.6 ± 4.8 | 0.7 ± 3.1 |
| Week 60 | 0.4 ± 5.1 | 0.8 ± 3.6 |
Exploratory outcome (Study 1): Ratings of food palatability using 100 mm visual analogue scales during a laboratory test meal. Score range 0-100 mm; higher scores indicate higher liking of the food taste.
| mm | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -1.9 ± 2.2 | -9.8 ± 2.2 |
| Week 40 | -1.4 ± 3.7 | -11.8 ± 2.5 |
| Week 60 | -6.2 ± 3.2 | -10.1 ± 2.4 |
Exploratory outcome (Study 1): Body image dissatisfaction (Body Satisfaction Scale). Mean of 13 items, score range 1-7, higher scores indicate greater body part dissatisfaction.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -0.4 ± 0.2 | -0.6 ± 0.1 |
| Week 40 | -0.6 ± 0.2 | -1.0 ± 0.1 |
| Week 60 | -0.5 ± 0.2 | -1.1 ± 0.2 |
Exploratory outcome (Study 1): Weight-related self stigmatization by the Weight Bias Internalization Scale. Mean of 11 items; score range 1-7; higher scores indicate greater weight-related self-stigmatization.
| Units on a scale | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) |
|---|---|---|
| Week 20 | -0.4 ± 0.1 | -0.4 ± 0.1 |
| Week 40 | -0.3 ± 0.2 | -0.7 ± 0.1 |
| Week 60 | -0.5 ± 0.2 | -0.9 ± 0.1 |
Supportive secondary outcome (Study 2): Body weight (kg) at week 72
| kg | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|
| Study 2 Body Weight (kg) | 98.3 ± 2.1 | 88.9 ± 1.3 | 85.3 ± 3.4 |
Collected over From enrollment until end of treatment, up to 72 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Treatment + Placebo (Weeks 0-60) | 0/48 (0%) | 0/48 (0%) | 42/48 (87.5%) |
| Behavioral Treatment + Medication (Weeks 0-60) | 0/72 (0%) | 3/72 (4.2%) | 70/72 (97.2%) |
| Continuous Placebo (Weeks 60-72) | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | 0/43 (0%) | 0/43 (0%) | 17/43 (39.5%) |
| Continued Medication (Semaglutide) (Weeks 60-72) | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|---|---|
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/48 | 1/72 | 0/20 | 0/43 | 0/10 |
| AppendicitisGastrointestinal disorders | — | 1/72 | 0/20 | 0/43 | 0/10 |
| CholelithiasisHepatobiliary disorders | — | 1/72 | 0/20 | 0/43 | 0/10 |
| Event | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Continuous Placebo (Weeks 60-72) | Medication (Semaglutide) Switched to Placebo (Weeks 60-72) | Continued Medication (Semaglutide) (Weeks 60-72) |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 12/48 | 53/72 | 2/20 | 0/43 | 0/10 |
| ConstipationGastrointestinal disorders | 8/48 | 38/72 | 0/20 | 1/43 | 1/10 |
| DiarrheaGastrointestinal disorders | 11/48 | 27/72 | 1/20 | 0/43 | 2/10 |
| VomitingGastrointestinal disorders | 3/48 | 25/72 | 1/20 | 2/43 | 1/10 |
| DyspepsiaGastrointestinal disorders | 8/48 | 24/72 | 1/20 | 0/43 | 0/10 |
| FatigueGeneral disorders | 8/48 | 23/72 | 0/20 | 2/43 | 0/10 |
| Abdominal painGastrointestinal disorders | 6/48 | 23/72 | 0/20 | 0/43 | 0/10 |
| HeadacheNervous system disorders | 6/48 | 17/72 | 0/20 | 0/43 | 1/10 |
| EructationGastrointestinal disorders | 3/48 | 17/72 | 0/20 | 0/43 | 1/10 |
| COVID-19Infections and infestations | 6/48 | 13/72 | 1/20 | 1/43 | 0/10 |
| Age, Continuous(Years) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| Mean | 44.2 ± 12.7 | 46.7 ± 11.5 | 45.7 ± 12.0 |
| Sex: Female, Male(Participants) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| Female | 39 | 55 | 94 |
| Male | 9 | 17 | 26 |
| Race/Ethnicity, Customized(Participants) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| White | 35 | 51 | 86 |
| Black | 8 | 18 | 26 |
| Asian | 3 | 2 | 5 |
| Other or more than one | 2 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| Hispanic | 5 | 6 | 11 |
| Middle Eastern/Arab | 1 | 2 | 3 |
| Both Hispanic and Middle Eastern/Arab | 0 | 1 | 1 |
| Not Hispanic or Middle Eastern/Arab | 42 | 63 | 105 |
| Body weight(kg) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| Mean | 106.2 ± 19.4 | 106.9 ± 21.4 | 106.6 ± 20.6 |
| Lunch intake(kcal) | Behavioral Treatment + Placebo (Weeks 0-60) | Behavioral Treatment + Medication (Weeks 0-60) | Total |
|---|---|---|---|
| Mean | 1053.0 ± 329.4 | 1050.6 ± 358.9 | 1051.5 ± 345.9 |
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Studies of the drug tested here: Semaglutide