Trial Outcomes & Findings for Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects (NCT NCT05548647)
NCT ID: NCT05548647
Last Updated: 2026-08-03
Results Overview
Primary outcome (Study 1)
COMPLETED
PHASE4
120 participants
S1: Change from baseline to weeks 20, 40, and 60
2026-08-03
Participant Flow
Participants were recruited between July 2022 and February 2024 via print and social media advertisements.
We sought to capitalize on the long-term design of Study 1 by conducting a separate, 12-week, medication withdrawal trial (Study 2) to compare subjects who discontinued semaglutide 2.4 mg to those who had never received active medication (continuous placebo). A very small number of subjects were randomized to continue taking semaglutide at week 60 to maintain blinding. Number of continued subjects was not sufficient for statistical comparison and their Study 2 results are not reported.
Participant milestones
| Measure |
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).
|
Behavioral Treatment + Medication (Weeks 0-60)
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
Only Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate Medication - switched to placebo and Continued medication prior to that timepoint.
|
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. Participant flow for this group is being used to show the number of participants, out of those who were originally assigned to Behavioral Treatment + Medication, who were enrolled in Study 2 and re-randomized to take placebo from weeks 60 - 72.
Only Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication groups prior to that timepoint.
|
Behavioral Treatment + Medication (Weeks 0-60) // Continuous Medication (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. Participant flow for this group is being used to show the number of participants, out of those who were originally assigned to Behavioral Treatment + Medication, who were enrolled in Study 2 and re-randomized to continue to take semaglutide (Continuous Medication) from weeks 60 - 72.
Only Study 1 completers who were on drug were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication prior to that timepoint.
Re-allocation of a small number of participants to Continuous Medication was used to maintain blinding of researchers and participants to treatment condition. (Re-randomization was conducted by staff not involved in the trial and thus both also remained blinded to original treatment assignment.) This group was not intended to be analyzed or subject to statistical comparisons.
|
|---|---|---|---|---|
|
Study 1: Weeks 0-60
STARTED
|
48
|
72
|
0
|
0
|
|
Study 1: Weeks 0-60
Week 20
|
37
|
70
|
0
|
0
|
|
Study 1: Weeks 0-60
Week 40
|
27
|
62
|
0
|
0
|
|
Study 1: Weeks 0-60
COMPLETED
|
26
|
61
|
0
|
0
|
|
Study 1: Weeks 0-60
NOT COMPLETED
|
22
|
11
|
0
|
0
|
|
Study 2: Weeks 60-72
STARTED
|
20
|
0
|
43
|
10
|
|
Study 2: Weeks 60-72
COMPLETED
|
18
|
0
|
41
|
9
|
|
Study 2: Weeks 60-72
NOT COMPLETED
|
2
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects
Baseline characteristics by cohort
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
At week 60, eligible placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group) in Study 2.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
At week 60, eligible medication-treated participants were re-randomized to be switched to placebo or continue active medication for an additional 12 weeks (i.e., continuous placebo group) in Study 2. Only Study 1 completers who were on drug at week 60 were eligible for participation in Study 2, and reassignment of the semaglutide group did not occur until week 60. Therefore it is not possible to separate the Medication - Switched to Placebo and Continued Medication groups prior to that timepoint, including at baseline of Phase 1.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 Years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
46.7 Years
STANDARD_DEVIATION 11.5 • n=20 Participants
|
45.7 Years
STANDARD_DEVIATION 12.0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=20 Participants
|
55 Participants
n=20 Participants
|
94 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other or more than one
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern/Arab
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Both Hispanic and Middle Eastern/Arab
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Middle Eastern/Arab
|
42 Participants
n=20 Participants
|
63 Participants
n=20 Participants
|
105 Participants
n=40 Participants
|
|
Body weight
|
106.2 kg
STANDARD_DEVIATION 19.4 • n=20 Participants
|
106.9 kg
STANDARD_DEVIATION 21.4 • n=20 Participants
|
106.6 kg
STANDARD_DEVIATION 20.6 • n=40 Participants
|
|
Lunch intake
|
1053.0 kcal
STANDARD_DEVIATION 329.4 • n=20 Participants
|
1050.6 kcal
STANDARD_DEVIATION 358.9 • n=20 Participants
|
1051.5 kcal
STANDARD_DEVIATION 345.9 • n=40 Participants
|
PRIMARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
Primary outcome (Study 1)
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Week 20
|
-75.1 kcal
Standard Error 52.6
|
-367.0 kcal
Standard Error 37.2
|
—
|
|
Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Week 40
|
-76.8 kcal
Standard Error 73.8
|
-317.0 kcal
Standard Error 49.7
|
—
|
|
Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Week 60
|
69.6 kcal
Standard Error 73.9
|
-200.0 kcal
Standard Error 50.1
|
—
|
PRIMARY outcome
Timeframe: S2: Endpoint comparison at week 72Population: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
Primary outcome (Study 2)
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
|
1073.0 kcal
Standard Error 71.1
|
951.8 kcal
Standard Error 42.9
|
657.7 kcal
Standard Error 81.5
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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).
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
Week 20
|
3.8 mm
Standard Error 2.6
|
16.0 mm
Standard Error 2.0
|
—
|
|
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
Week 40
|
-0.5 mm
Standard Error 3.6
|
6.9 mm
Standard Error 2.4
|
—
|
|
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
Week 60
|
1.4 mm
Standard Error 3.6
|
2.3 mm
Standard Error 2.4
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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).
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
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)
Week 20
|
1112.3 mm*min
Standard Error 665.2
|
3309.3 mm*min
Standard Error 470.4
|
—
|
|
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)
Week 40
|
645.5 mm*min
Standard Error 1125.5
|
2595.1 mm*min
Standard Error 608.8
|
—
|
|
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)
Week 60
|
712.5 mm*min
Standard Error 1050.4
|
2065.8 mm*min
Standard Error 650.7
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
Week 20
|
-14.4 mm
Standard Error 4.0
|
-31.9 mm
Standard Error 2.7
|
—
|
|
Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
Week 40
|
-14.6 mm
Standard Error 5.0
|
-25.4 mm
Standard Error 3.2
|
—
|
|
Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
Week 60
|
-10.6 mm
Standard Error 4.4
|
-17.4 mm
Standard Error 3.0
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
Week 20
|
8.9 mm
Standard Error 3.7
|
10.8 mm
Standard Error 2.5
|
—
|
|
Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
Week 40
|
8.2 mm
Standard Error 4.4
|
4.9 mm
Standard Error 2.9
|
—
|
|
Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
Week 60
|
5.9 mm
Standard Error 4.1
|
4.3 mm
Standard Error 2.8
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
Week 20
|
-14.7 mm
Standard Error 3.7
|
-29.6 mm
Standard Error 2.6
|
—
|
|
Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
Week 40
|
-17.0 mm
Standard Error 4.1
|
-24.9 mm
Standard Error 2.7
|
—
|
|
Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
Week 60
|
-13.1 mm
Standard Error 3.6
|
-22.4 mm
Standard Error 2.6
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
Week 20
|
-0.55 Units on a scale
Standard Error 0.13
|
-0.98 Units on a scale
Standard Error 0.09
|
—
|
|
Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
Week 40
|
-0.51 Units on a scale
Standard Error 0.15
|
-1.10 Units on a scale
Standard Error 0.09
|
—
|
|
Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
Week 60
|
-0.67 Units on a scale
Standard Error 0.18
|
-1.01 Units on a scale
Standard Error 0.12
|
—
|
SECONDARY outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
Week 20
|
-3.7 Units on a scale
Standard Error 4.1
|
-5.9 Units on a scale
Standard Error 2.7
|
—
|
|
Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
Week 40
|
4.7 Units on a scale
Standard Error 4.7
|
-0.6 Units on a scale
Standard Error 2.9
|
—
|
|
Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
Week 60
|
2.6 Units on a scale
Standard Error 5.1
|
-1.9 Units on a scale
Standard Error 3.4
|
—
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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).
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
|
33.7 mm
Standard Error 3.8
|
32.7 mm
Standard Error 2.3
|
47.7 mm
Standard Error 5.3
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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).
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
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 mm*min
Standard Error 997
|
14533 mm*min
Standard Error 668
|
16914 mm*min
Standard Error 1292
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
|
48.5 mm
Standard Error 5.2
|
63.6 mm
Standard Error 3.5
|
38.5 mm
Standard Error 7.7
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
|
57.4 mm
Standard Error 5.0
|
59.4 mm
Standard Error 3.5
|
76.7 mm
Standard Error 6.9
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
|
42.7 mm
Standard Error 5.0
|
62.9 mm
Standard Error 3.5
|
26.4 mm
Standard Error 7.4
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
|
2.1 Units on a scale
Standard Error 0.2
|
2.5 Units on a scale
Standard Error 0.1
|
1.7 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
|
4.6 Units on a scale
Standard Error 4.8
|
-7.2 Units on a scale
Standard Error 3.0
|
-2.9 Units on a scale
Standard Error 8.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
Supportive secondary outcome (Study 1): Body weight change (kg)
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Body Weight (kg)
Week 60
|
-3.6 kg
Standard Error 1.9
|
-15.4 kg
Standard Error 1.4
|
—
|
|
Study 1 Body Weight (kg)
Week 20
|
-5.2 kg
Standard Error 0.9
|
-9.9 kg
Standard Error 0.6
|
—
|
|
Study 1 Body Weight (kg)
Week 40
|
-6.0 kg
Standard Error 1.4
|
-15.0 kg
Standard Error 1.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Craving Control Over the Past Week as Measured by the COEQ
Week 20
|
19.3 mm
Standard Error 3.8
|
32.2 mm
Standard Error 2.8
|
—
|
|
Study 1 Craving Control Over the Past Week as Measured by the COEQ
Week 40
|
15.8 mm
Standard Error 4.1
|
30.2 mm
Standard Error 2.7
|
—
|
|
Study 1 Craving Control Over the Past Week as Measured by the COEQ
Week 60
|
14.7 mm
Standard Error 4.6
|
27.1 mm
Standard Error 3.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Craving for Savory Over the Past Week as Measured by the COEQ
Week 20
|
-18.5 mm
Standard Error 3.7
|
-29.9 mm
Standard Error 2.6
|
—
|
|
Study 1 Craving for Savory Over the Past Week as Measured by the COEQ
Week 40
|
-16.6 mm
Standard Error 4.0
|
-27.1 mm
Standard Error 2.6
|
—
|
|
Study 1 Craving for Savory Over the Past Week as Measured by the COEQ
Week 60
|
-14.9 mm
Standard Error 4.4
|
-19.8 mm
Standard Error 2.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ
Week 20
|
-17.5 mm
Standard Error 3.9
|
-23.0 mm
Standard Error 2.8
|
—
|
|
Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ
Week 40
|
-17.5 mm
Standard Error 3.9
|
-15.8 mm
Standard Error 2.9
|
—
|
|
Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ
Week 60
|
-15.0 mm
Standard Error 4.2
|
-11.7 mm
Standard Error 3.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait
Week 20
|
-11.0 Units on a scale
Standard Error 2.6
|
-18.4 Units on a scale
Standard Error 1.8
|
—
|
|
Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait
Week 40
|
-8.8 Units on a scale
Standard Error 2.9
|
-20.2 Units on a scale
Standard Error 1.9
|
—
|
|
Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait
Week 60
|
-9.7 Units on a scale
Standard Error 3.6
|
-18.6 Units on a scale
Standard Error 2.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Explicit Liking of High-fat Savory Foods (LFPT)
Week 20
|
-5.1 mm
Standard Deviation 4.0
|
-15.4 mm
Standard Deviation 2.5
|
—
|
|
Study 1 Explicit Liking of High-fat Savory Foods (LFPT)
Week 40
|
-2.2 mm
Standard Deviation 5.5
|
-10.3 mm
Standard Deviation 3.3
|
—
|
|
Study 1 Explicit Liking of High-fat Savory Foods (LFPT)
Week 60
|
-7.0 mm
Standard Deviation 4.8
|
-9.8 mm
Standard Deviation 3.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Cognitive Restraint (Eating Inventory)
Week 20
|
3.8 Units on a scale
Standard Error 0.6
|
4.5 Units on a scale
Standard Error 0.4
|
—
|
|
Study 1 Cognitive Restraint (Eating Inventory)
Week 40
|
3.5 Units on a scale
Standard Error 0.7
|
4.0 Units on a scale
Standard Error 0.5
|
—
|
|
Study 1 Cognitive Restraint (Eating Inventory)
Week 60
|
2.3 Units on a scale
Standard Error 0.5
|
3.2 Units on a scale
Standard Error 0.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Disinhibition (Eating Inventory)
Week 60
|
-1.6 Units on a scale
Standard Error 0.6
|
-3.5 Units on a scale
Standard Error 0.4
|
—
|
|
Study 1 Disinhibition (Eating Inventory)
Week 20
|
-1.4 Units on a scale
Standard Error 0.5
|
-3.3 Units on a scale
Standard Error 0.3
|
—
|
|
Study 1 Disinhibition (Eating Inventory)
Week 40
|
-1.3 Units on a scale
Standard Error 0.6
|
-3.8 Units on a scale
Standard Error 0.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Weight-related Self-efficacy
Week 20
|
10.3 Units on a scale
Standard Error 2.6
|
14.5 Units on a scale
Standard Error 1.9
|
—
|
|
Study 1 Weight-related Self-efficacy
Week 40
|
8.6 Units on a scale
Standard Error 3.5
|
16.6 Units on a scale
Standard Error 2.3
|
—
|
|
Study 1 Weight-related Self-efficacy
Week 60
|
3.9 Units on a scale
Standard Error 3.9
|
14.5 Units on a scale
Standard Error 2.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Mood as Assessed Using the PHQ-9
Week 20
|
-1.2 Units on a scale
Standard Error 0.6
|
-1.0 Units on a scale
Standard Error 0.4
|
—
|
|
Study 1 Mood as Assessed Using the PHQ-9
Week 40
|
-2.0 Units on a scale
Standard Error 0.6
|
-1.6 Units on a scale
Standard Error 0.4
|
—
|
|
Study 1 Mood as Assessed Using the PHQ-9
Week 60
|
-1.4 Units on a scale
Standard Error 0.8
|
-2.0 Units on a scale
Standard Error 0.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)
Week 20
|
-4.2 Binge episodes
Standard Error 2.3
|
-4.9 Binge episodes
Standard Error 1.3
|
—
|
|
Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)
Week 40
|
-3.9 Binge episodes
Standard Error 2.3
|
-5.0 Binge episodes
Standard Error 1.3
|
—
|
|
Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)
Week 60
|
-3.7 Binge episodes
Standard Error 2.4
|
-4.9 Binge episodes
Standard Error 1.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)
Week 20
|
-0.5 Units on a scale
Standard Error 0.1
|
-0.8 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)
Week 40
|
-0.5 Units on a scale
Standard Error 0.1
|
-0.9 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)
Week 60
|
-0.6 Units on a scale
Standard Error 0.1
|
-0.8 Units on a scale
Standard Error 0.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale
Week 20
|
-1.3 Number of symptoms
Standard Error 0.4
|
-1.6 Number of symptoms
Standard Error 0.3
|
—
|
|
Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale
Week 40
|
-1.8 Number of symptoms
Standard Error 0.4
|
-1.9 Number of symptoms
Standard Error 0.2
|
—
|
|
Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale
Week 60
|
-1.8 Number of symptoms
Standard Error 0.4
|
-2.1 Number of symptoms
Standard Error 0.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])
Week 60
|
-1.1 Units on a scale
Standard Error 0.9
|
-3.8 Units on a scale
Standard Error 0.6
|
—
|
|
Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])
Week 20
|
0.2 Units on a scale
Standard Error 0.8
|
-1.9 Units on a scale
Standard Error 0.6
|
—
|
|
Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])
Week 40
|
0.6 Units on a scale
Standard Error 0.9
|
-2.6 Units on a scale
Standard Error 0.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Ratings of Nausea When Fasting
Week 20
|
0.8 mm
Standard Error 4.3
|
7.6 mm
Standard Error 3.0
|
—
|
|
Study 1 Ratings of Nausea When Fasting
Week 40
|
-0.6 mm
Standard Error 4.8
|
0.7 mm
Standard Error 3.1
|
—
|
|
Study 1 Ratings of Nausea When Fasting
Week 60
|
0.4 mm
Standard Error 5.1
|
0.8 mm
Standard Error 3.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Ratings of Food Palatability
Week 20
|
-1.9 mm
Standard Error 2.2
|
-9.8 mm
Standard Error 2.2
|
—
|
|
Study 1 Ratings of Food Palatability
Week 40
|
-1.4 mm
Standard Error 3.7
|
-11.8 mm
Standard Error 2.5
|
—
|
|
Study 1 Ratings of Food Palatability
Week 60
|
-6.2 mm
Standard Error 3.2
|
-10.1 mm
Standard Error 2.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)
Week 20
|
-0.4 Units on a scale
Standard Error 0.2
|
-0.6 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)
Week 40
|
-0.6 Units on a scale
Standard Error 0.2
|
-1.0 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)
Week 60
|
-0.5 Units on a scale
Standard Error 0.2
|
-1.1 Units on a scale
Standard Error 0.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S1: Change from baseline to weeks 20, 40, and 60Population: Data are adjusted estimated mean changes ± SE (95% CI) after controlling for baseline values for the intention-to-treat population (N = 120). Missing data were estimated using jump-to-reference multiple imputation, which assumes that missing scores from semaglutide-treated individuals approximate the mean of the placebo group.
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.
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
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.
|
|---|---|---|---|
|
Study 1 Weight-related Self Stigmatization
Week 20
|
-0.4 Units on a scale
Standard Error 0.1
|
-0.4 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Weight-related Self Stigmatization
Week 40
|
-0.3 Units on a scale
Standard Error 0.2
|
-0.7 Units on a scale
Standard Error 0.1
|
—
|
|
Study 1 Weight-related Self Stigmatization
Week 60
|
-0.5 Units on a scale
Standard Error 0.2
|
-0.9 Units on a scale
Standard Error 0.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: S2: Week 72 endpoint controlling for S1 baselinePopulation: Data are adjusted estimated means ± SE (95% CI) after controlling for baseline values for the Study 2 intention-to-treat population (N = 73). Missing data were estimated using multiple imputation. The goal of Study 2 was to compare Switched to Placebo to Continuous Placebo at week 72. A small number of subjects were re-randomized to Continued Medication in order to maintain blinding. Number of Continued Medication subjects was not sufficient for statistical comparison.
Supportive secondary outcome (Study 2): Body weight (kg) at week 72
Outcome measures
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=20 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=43 Participants
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 Participants
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.
|
|---|---|---|---|
|
Study 2 Body Weight (kg)
|
98.3 kg
Standard Error 2.1
|
88.9 kg
Standard Error 1.3
|
85.3 kg
Standard Error 3.4
|
Adverse Events
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)
Serious adverse events
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 participants at risk
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 participants at risk
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continuous Placebo (Weeks 60-72)
n=20 participants at risk
At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).
|
Medication (Semaglutide) Switched to Placebo (Weeks 60-72)
n=43 participants at risk
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.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 participants at risk
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.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/48 • From enrollment until end of treatment, up to 72 weeks
|
1.4%
1/72 • Number of events 1 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/48 • From enrollment until end of treatment, up to 72 weeks
|
1.4%
1/72 • Number of events 1 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/48 • From enrollment until end of treatment, up to 72 weeks
|
1.4%
1/72 • Number of events 1 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
Other adverse events
| Measure |
Behavioral Treatment + Placebo (Weeks 0-60)
n=48 participants at risk
Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.
|
Behavioral Treatment + Medication (Weeks 0-60)
n=72 participants at risk
Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.
|
Continuous Placebo (Weeks 60-72)
n=20 participants at risk
At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).
|
Medication (Semaglutide) Switched to Placebo (Weeks 60-72)
n=43 participants at risk
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.
|
Continued Medication (Semaglutide) (Weeks 60-72)
n=10 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
12/48 • From enrollment until end of treatment, up to 72 weeks
|
73.6%
53/72 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
2/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
8/48 • From enrollment until end of treatment, up to 72 weeks
|
52.8%
38/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
2.3%
1/43 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
1/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
22.9%
11/48 • From enrollment until end of treatment, up to 72 weeks
|
37.5%
27/72 • From enrollment until end of treatment, up to 72 weeks
|
5.0%
1/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
20.0%
2/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
8/48 • From enrollment until end of treatment, up to 72 weeks
|
33.3%
24/72 • From enrollment until end of treatment, up to 72 weeks
|
5.0%
1/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
General disorders
Fatigue
|
16.7%
8/48 • From enrollment until end of treatment, up to 72 weeks
|
31.9%
23/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
6/48 • From enrollment until end of treatment, up to 72 weeks
|
31.9%
23/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
34.7%
25/72 • From enrollment until end of treatment, up to 72 weeks
|
5.0%
1/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
1/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Nervous system disorders
Headache
|
12.5%
6/48 • From enrollment until end of treatment, up to 72 weeks
|
23.6%
17/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
1/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Eructation
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
23.6%
17/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
1/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Infections and infestations
COVID-19
|
12.5%
6/48 • From enrollment until end of treatment, up to 72 weeks
|
18.1%
13/72 • From enrollment until end of treatment, up to 72 weeks
|
5.0%
1/20 • From enrollment until end of treatment, up to 72 weeks
|
2.3%
1/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
6/48 • From enrollment until end of treatment, up to 72 weeks
|
15.3%
11/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
16.7%
12/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
4/48 • From enrollment until end of treatment, up to 72 weeks
|
15.3%
11/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
12.5%
6/48 • From enrollment until end of treatment, up to 72 weeks
|
11.1%
8/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
4.7%
2/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
2/48 • From enrollment until end of treatment, up to 72 weeks
|
12.5%
9/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
1/48 • From enrollment until end of treatment, up to 72 weeks
|
11.1%
8/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
2.3%
1/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
8.3%
6/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
10.0%
1/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Injury, poisoning and procedural complications
Injection site bruising
|
8.3%
4/48 • From enrollment until end of treatment, up to 72 weeks
|
5.6%
4/72 • From enrollment until end of treatment, up to 72 weeks
|
5.0%
1/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/48 • From enrollment until end of treatment, up to 72 weeks
|
9.7%
7/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
2.3%
1/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • From enrollment until end of treatment, up to 72 weeks
|
8.3%
6/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Psychiatric disorders
Insomnia
|
4.2%
2/48 • From enrollment until end of treatment, up to 72 weeks
|
6.9%
5/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Psychiatric disorders
Depressed mood
|
2.1%
1/48 • From enrollment until end of treatment, up to 72 weeks
|
6.9%
5/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
2.3%
1/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Infections and infestations
Sinusitis
|
2.1%
1/48 • From enrollment until end of treatment, up to 72 weeks
|
5.6%
4/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
General disorders
Thirst
|
2.1%
1/48 • From enrollment until end of treatment, up to 72 weeks
|
5.6%
4/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/48 • From enrollment until end of treatment, up to 72 weeks
|
5.6%
4/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Injury, poisoning and procedural complications
Injection site pain
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
3/48 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/72 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/20 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/43 • From enrollment until end of treatment, up to 72 weeks
|
0.00%
0/10 • From enrollment until end of treatment, up to 72 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place