Trial Outcomes & Findings for Effects of Semaglutide in HIV-Associated Lipohypertrophy (NCT NCT04019197)
NCT ID: NCT04019197
Last Updated: 2026-05-04
Results Overview
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
32 weeks
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Participants With HIV and Lipohypertrophy: Semaglutide Arm
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Semaglutide Injectable Product: semaglutide subcutaneous injection
|
Participants With HIV and Lipohypertrophy: Placebo Arm
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Placebo: placebo injection
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Participants With HIV and Lipohypertrophy: Semaglutide Arm
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Semaglutide Injectable Product: semaglutide subcutaneous injection
|
Participants With HIV and Lipohypertrophy: Placebo Arm
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Placebo: placebo injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Incarcerated
|
1
|
0
|
Baseline Characteristics
Effects of Semaglutide in HIV-Associated Lipohypertrophy
Baseline characteristics by cohort
| Measure |
Participants With HIV and Lipohypertrophy: Semaglutide Arm
n=54 Participants
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Semaglutide Injectable Product: semaglutide subcutaneous injection
|
Participants With HIV and Lipohypertrophy: Placebo Arm
n=54 Participants
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Placebo: placebo injection
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=54 Participants
|
53 years
n=60 Participants
|
53 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=54 Participants
|
27 Participants
n=60 Participants
|
43 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=54 Participants
|
27 Participants
n=60 Participants
|
65 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=54 Participants
|
49 Participants
n=60 Participants
|
99 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=54 Participants
|
34 Participants
n=60 Participants
|
67 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
38 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
54 participants
n=60 Participants
|
108 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 32 weeksPopulation: absolute changes for primary outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Total abdominal adipose tissue, cm^2
|
6.65 cm^2
Interval -18.9 to 42.5
|
-51.75 cm^2
Interval -84.1 to -2.2
|
|
Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Subcutaneous abdominal adipose tissue, cm^2
|
3.90 cm^2
Interval -15.0 to 20.2
|
-34.65 cm^2
Interval -64.4 to -12.4
|
|
Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Visceral abdominal adipose tissue, cm^2
|
2.60 cm^2
Interval -13.6 to 19.6
|
-9.45 cm^2
Interval -25.8 to 3.0
|
PRIMARY outcome
Timeframe: 32 weeksPopulation: absolute changes for primary outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of body fat (total body fat, total limb fat, total trunk fat) as measured in mass via whole-body DXA scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline
Total Body Fat, kg
|
0.25 kg
Interval -2.08 to 2.29
|
-4.82 kg
Interval -7.25 to -2.44
|
|
Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline
Total Limb Fat, kg
|
-0.14 kg
Interval -0.72 to 0.61
|
-1.79 kg
Interval -3.45 to -1.06
|
|
Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline
Total Trunk Fat, kg
|
0.17 kg
Interval -1.22 to 1.27
|
-2.86 kg
Interval -4.47 to -1.4
|
PRIMARY outcome
Timeframe: 32 weeksPopulation: absolute changes over 32 weeks in each group
Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, in total pericardial fat as measured by chest CT scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline
|
0.00 mL
Interval -10.3 to 10.4
|
-1.85 mL
Interval -17.9 to 11.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in liver fat (i.e., density) over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan. (increased density = less fat)
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline
|
0.39 Hounsfield unit
Interval -1.95 to 4.23
|
1.27 Hounsfield unit
Interval -2.4 to 4.43
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in lean body mass over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline
|
-0.17 kg
Interval -11.61 to 0.66
|
-2.94 kg
Interval -3.89 to -1.49
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in total right psoas muscle in each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline
|
-0.20 cm^2
Interval -2.7 to 2.1
|
0.10 cm^2
Interval -1.9 to 1.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in quality of abdominal fat for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan. (less negative = higher quality)
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Abdominal total adipose tissue, Hounsfield unit
|
6.65 Hounsfield units
Interval -18.9 to 42.5
|
0.40 Hounsfield units
Interval -2.3 to 2.5
|
|
Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Abdominal subcutaneous adipose tissue, Hounsfield unit
|
3.90 Hounsfield units
Interval -15.0 to 20.2
|
-34.65 Hounsfield units
Interval -64.4 to -12.4
|
|
Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Abdominal visceral adipose tissue, Hounsfield unit
|
2.60 Hounsfield units
Interval -13.6 to 19.6
|
-9.45 Hounsfield units
Interval -25.8 to 3.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in quality of a total pericardial fat for each group
Effects of semaglutide will be investigated, including a comparison of changes overtime between participants receiving semaglutide vs. placebo, on the quality of total pericardial fat as measured by density via CT scan. (less negative = higher quality)
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline
|
0.00 Hounsfield units
Interval -1.4 to 0.3
|
0.20 Hounsfield units
Interval -0.9 to 1.1
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in right psoas muscle density
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured by density via CT scan.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline
|
-0.20 Hounsfield units
Interval -2.7 to 2.1
|
0.10 Hounsfield units
Interval -1.9 to 1.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline
|
0.16 kg
Interval -2.54 to 2.59
|
-7.82 kg
Interval -11.88 to -3.9
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline
|
-0.02 kg/m^2
Interval -1.05 to 0.66
|
-2.64 kg/m^2
Interval -4.0 to -1.37
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline
|
0.17 cm
Interval -2.33 to 2.67
|
-4.50 cm
Interval -11.17 to -0.5
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline
|
-0.01 ratio
Interval -0.05 to 0.02
|
-0.01 ratio
Interval -0.04 to 0.02
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose
|
0.00 mg/dL
Interval -11.0 to 9.0
|
0.50 mg/dL
Interval -5.0 to 7.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose
|
-2.00 mg/mL
Interval -16.0 to 16.0
|
-11.50 mg/mL
Interval -41.5 to 2.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline
|
0.10 % of glycosylated hemoglobin
Interval -0.1 to 0.2
|
-0.20 % of glycosylated hemoglobin
Interval -0.6 to -0.1
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes of outcome variables over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR (calculated based on insulin levels and glucose levels)
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline
Fasting insulin, uIU/mL
|
-1.00 uIU/mL
Interval -6.0 to 4.0
|
2.00 uIU/mL
Interval -3.0 to 7.0
|
|
Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline
2-h OGTT insulin, uIU/mL
|
2.00 uIU/mL
Interval -18.0 to 26.0
|
4.50 uIU/mL
Interval -13.5 to 18.5
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes of outcome variables over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels and HOMA-IR, calculated based on insulin levels and glucose levels with the formula (Fasting insulin, uIU/mL)\*(Fasting glucose, mg/dL) / 405). Reference levels for HOMA-IR insulin resistance range from 0.5 - 2.9 with higher values suggesting higher insulin resistance.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline
Fasting HOMA-IR
|
-0.37 index
Interval -1.58 to 0.86
|
0.33 index
Interval -0.76 to 1.93
|
|
Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline
2-h OGTT HOMA-IR
|
1.30 index
Interval -6.26 to 7.19
|
-0.29 index
Interval -6.94 to 3.98
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in outcome variable over 32 weeks in each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline
Total cholesterol, mg/dL
|
-10.50 mg/dL
Interval -27.0 to 7.0
|
-12.5 mg/dL
Interval -28.0 to -3.0
|
|
Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline
High-density lipoprotein cholesterol, mg/dL
|
-1.60 mg/dL
Interval -5.3 to 3.0
|
-2.50 mg/dL
Interval -6.3 to 2.2
|
|
Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline
Low-density lipoprotein cholesterol, mg/dL
|
-6.00 mg/dL
Interval -20.0 to 7.0
|
-9.00 mg/dL
Interval -21.0 to 0.0
|
|
Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline
Very low-density lipoprotein cholesterol, mg/dL
|
-2.00 mg/dL
Interval -10.0 to 6.0
|
0.00 mg/dL
Interval -7.0 to 3.0
|
|
Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline
Triglycerides, mg/dL
|
-13.00 mg/dL
Interval -50.0 to 25.0
|
-1.00 mg/dL
Interval -33.0 to 14.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline
|
2.00 beats/minute
Interval -6.0 to 8.0
|
1.50 beats/minute
Interval -9.0 to 10.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline
Systolic blood pressure, mmHg
|
1.00 mmHg
Interval -7.0 to 9.0
|
-4.00 mmHg
Interval -15.0 to 7.0
|
|
Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline
Diastolic blood pressure, mmHg
|
3.50 mmHg
Interval -6.0 to 8.0
|
-1.50 mmHg
Interval -7.0 to 2.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in 10-year ASCVD risk estimate
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in overall cardiovascular disease (CVD) risk. 10-year atherosclerotic cardiovascular disease risk was estimated using the American College of Cardiology's atherosclerotic cardiovascular disease risk estimator plus (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). 10-year risk for ASCVD is categorized as: Low-risk (\<5%), Borderline risk (5% to 7.4%), Intermediate risk (7.5% to 19.9%), High risk (≥20%); minimum to maximum values of 0-100% are required to interpret the median 10-year atherosclerotic cardiovascular disease risk.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline
|
0.40 10-year ASCVD risk estimate %
Interval -0.6 to 1.1
|
-0.30 10-year ASCVD risk estimate %
Interval -1.7 to 0.3
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute change in Daily estimated total calories, kcal (dietary intake)
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on dietary intake via comprehensive dietary intake assessments.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline
|
17.84 Kcal
Interval -286.92 to 386.33
|
137.33 Kcal
Interval -240.31 to 388.87
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes in estimated weekly physical activity
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on physical activity status via comprehensive physical activity assessments \[International Physical Activity Questionnaire Short Version (physical activity across the previous 7 days)\]
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline
Low intensity, minutes per week
|
-75.00 minutes per week
Interval -100.0 to 51.14
|
-85.71 minutes per week
Interval -100.0 to 0.0
|
|
Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline
Moderate intensity, minutes per week
|
-25.00 minutes per week
Interval -50.0 to 60.0
|
-29.17 minutes per week
Interval -50.0 to 50.0
|
|
Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline
High intensity, minutes per week
|
0.00 minutes per week
Interval -20.0 to 50.0
|
21.11 minutes per week
Interval -32.29 to 100.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: General adverse event data
Safety of semaglutide in HIV will be investigated, including a comparison between participants receiving semaglutide vs. placebo, on adverse events, side effects, and related safety endpoints.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Safety Analyses
Not study-related adverse events- Elevated total bilirubin (all grade 1)
|
1 Participants
|
6 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated alanine transaminase
|
6 Participants
|
5 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated alanine transaminase: Grade 1
|
4 Participants
|
3 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated alanine transaminase: Grade 2
|
2 Participants
|
2 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated aspartate aminotransferase
|
4 Participants
|
3 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 1
|
3 Participants
|
3 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 2
|
1 Participants
|
0 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated glucose
|
39 Participants
|
25 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated glucose: Grade 1
|
38 Participants
|
24 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated glucose: Grade 2
|
1 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Any gastrointestinal disorder
|
27 Participants
|
35 Participants
|
|
Safety Analyses
Not study-related adverse events- Nausea
|
7 Participants
|
15 Participants
|
|
Safety Analyses
Not study-related adverse events- Vomiting
|
3 Participants
|
8 Participants
|
|
Safety Analyses
Not study-related adverse events- Diarrhoea or loose stools
|
10 Participants
|
7 Participants
|
|
Safety Analyses
Not study-related adverse events- Abdominal pain
|
1 Participants
|
4 Participants
|
|
Safety Analyses
Not study-related adverse events- Constipation or irregular bowel movements
|
5 Participants
|
16 Participants
|
|
Safety Analyses
Not study-related adverse events- Bloating or fullness
|
2 Participants
|
2 Participants
|
|
Safety Analyses
Not study-related adverse events- Dyspepsia
|
0 Participants
|
11 Participants
|
|
Safety Analyses
Not study-related adverse events- Eructation or flatulence
|
6 Participants
|
10 Participants
|
|
Safety Analyses
Not study-related adverse events- Gastritis
|
0 Participants
|
3 Participants
|
|
Safety Analyses
Not study-related adverse events- Gastroesophageal reflux disease
|
6 Participants
|
14 Participants
|
|
Safety Analyses
Not study-related adverse events- Decreased appetite or changes in food cravings or tolerance
|
4 Participants
|
8 Participants
|
|
Safety Analyses
Not study-related adverse events- Fatigue
|
6 Participants
|
14 Participants
|
|
Safety Analyses
Not study-related adverse events- Dysgeusia
|
1 Participants
|
4 Participants
|
|
Safety Analyses
Not study-related adverse events- Dizziness
|
1 Participants
|
6 Participants
|
|
Safety Analyses
Not study-related adverse events- Headache
|
10 Participants
|
12 Participants
|
|
Safety Analyses
Not study-related adverse events- Anxiety or nervousness
|
2 Participants
|
5 Participants
|
|
Safety Analyses
Not study-related adverse events- Irritability or moodiness
|
4 Participants
|
5 Participants
|
|
Safety Analyses
Not study-related adverse events- Sweating
|
3 Participants
|
2 Participants
|
|
Safety Analyses
Not study-related adverse events- Hunger
|
8 Participants
|
3 Participants
|
|
Safety Analyses
Not study-related adverse events- Generalized myalgias
|
1 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Shakiness
|
3 Participants
|
2 Participants
|
|
Safety Analyses
Not study-related adverse events- Weakness
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Light-headedness
|
1 Participants
|
0 Participants
|
|
Safety Analyses
Not study-related adverse events- Temporary neurosensory alteration
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Hiccups
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Diabetes
|
2 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated creatinine: Grade 2
|
3 Participants
|
6 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated creatinine: Grade 3
|
1 Participants
|
0 Participants
|
|
Safety Analyses
study-related adverse events: Injection site reactions (all grade 1)
|
2 Participants
|
4 Participants
|
|
Safety Analyses
possibly-related adverse events- Elevated lipase
|
2 Participants
|
4 Participants
|
|
Safety Analyses
possibly-related adverse events- Elevated lipase: Grade 1
|
2 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events-Elevated lipase: Grade 2
|
0 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events Elevated creatinine
|
1 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Cholelithiasis
|
0 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events- Any gastrointestinal disorder
|
15 Participants
|
18 Participants
|
|
Safety Analyses
possibly-related adverse events- Nausea
|
4 Participants
|
6 Participants
|
|
Safety Analyses
possibly-related adverse events- Vomiting
|
0 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Diarrhoea or loose stools
|
7 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Abdominal pain
|
2 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Constipation or irregular bowel movements
|
2 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events- Eructation or flatulence
|
4 Participants
|
5 Participants
|
|
Safety Analyses
possibly-related adverse events- Gastroesophageal reflux disease
|
1 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events- Bloating or fullness
|
0 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Dyspepsia
|
2 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Gastritis
|
1 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Decreased appetite or changes in food cravings or tolerance
|
1 Participants
|
7 Participants
|
|
Safety Analyses
possibly-related adverse events- Fatigue
|
2 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events- Dysgeusia
|
2 Participants
|
3 Participants
|
|
Safety Analyses
possibly-related adverse events- Dizziness
|
3 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Headache
|
0 Participants
|
3 Participants
|
|
Safety Analyses
possibly-related adverse events- Anxiety or nervousness
|
1 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Irritability or moodiness
|
2 Participants
|
1 Participants
|
|
Safety Analyses
possibly-related adverse events- Sweating
|
3 Participants
|
2 Participants
|
|
Safety Analyses
possibly-related adverse events- Hunger
|
2 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Generalized myalgias
|
1 Participants
|
0 Participants
|
|
Safety Analyses
possibly-related adverse events- Scalp alopecia
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated lipase
|
3 Participants
|
8 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated lipase: Grade 1
|
2 Participants
|
7 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated lipase: Grade 2
|
1 Participants
|
1 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated creatinine
|
13 Participants
|
24 Participants
|
|
Safety Analyses
Not study-related adverse events- Elevated creatinine: Grade 1
|
9 Participants
|
18 Participants
|
|
Safety Analyses
Possibly related adverse events
|
17 Participants
|
21 Participants
|
|
Safety Analyses
≥1 possibly related or study-related adverse event
|
18 Participants
|
24 Participants
|
|
Safety Analyses
Adverse events or side-effects leading to premature trial discontinuation
|
1 Participants
|
4 Participants
|
|
Safety Analyses
Grade 4 elevated lipase (week 14)
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Grade 1 elevated lipase, gastrointestinal symptoms (week 10)
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Grade 1 gastrointestinal and systemic symptoms (week 12)
|
0 Participants
|
1 Participants
|
|
Safety Analyses
Grade 1 memory impairment (week 17)
|
1 Participants
|
0 Participants
|
|
Safety Analyses
Weight loss (week 17)
|
0 Participants
|
1 Participants
|
|
Safety Analyses
study-related adverse events: Elevated lipase
|
0 Participants
|
1 Participants
|
|
Safety Analyses
≥1 adverse event
|
53 Participants
|
54 Participants
|
|
Safety Analyses
Serious study-related adverse events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sTNFR-I, ng/mL
|
-0.06 ng/mL
Interval -0.24 to 0.16
|
-0.07 ng/mL
Interval -0.23 to 0.19
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sTNFR-II, ng/mL
|
0.07 ng/mL
Interval -0.68 to 0.7
|
-0.16 ng/mL
Interval -0.7 to 0.35
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sCD14, ng/mL
|
-106.11 ng/mL
Interval -364.4 to 296.23
|
-130.83 ng/mL
Interval -446.01 to 136.27
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sCD163, ng/mL
|
-15.23 ng/mL
Interval -107.35 to 79.16
|
-61.30 ng/mL
Interval -162.44 to 35.78
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sVCAM-1, ng/mL
|
-21.21 ng/mL
Interval -68.58 to 93.5
|
2.44 ng/mL
Interval -94.83 to 81.83
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (sTNFR-I, sTNFR-II, sCD14, sCD163, sVCAM-1, sICAM-1) at Week 32 Compared to Baseline
sICAM-1, ng/mL
|
-6.85 ng/mL
Interval -36.64 to 31.19
|
-4.99 ng/mL
Interval -36.54 to 33.0
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline
hsCRP, µg/mL
|
-0.11 µg/mL
Interval -1.3 to 2.37
|
-1.17 µg/mL
Interval -3.09 to 0.15
|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline
D-dimer, µg/mL
|
0.02 µg/mL
Interval -0.12 to 0.14
|
0.05 µg/mL
Interval -0.14 to 0.19
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline
|
-0.25 pg/mL
Interval -1.66 to 0.74
|
-0.39 pg/mL
Interval -1.62 to 0.3
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: absolute changes for outcomes measures over 32 weeks for each group
Effects of semaglutide on cellular markers of inflammation and immune activation markers will be investigated to assess overall level of systemic immune activation, including a comparison of changes over time between participants receiving semaglutide vs. placebo. Cellular markers of immune activation were measured on cryopreserved PBMCs by flow cytometry. Monocyte subsets were identified based on CD14 and CD16 expression, including CD14+ CD16+ (inflammatory) and CD14dim CD16+ (patrolling) monocytes; activated CD4+ and CD8+ lymphocytes were identified as those expressing both CD38 and human leukocyte antigen (HLA)-DR; senescence/exhaustion was measured among T cells based on expression of CD28 and CD57 (CD28-CD57+) and on positive expression of PD-1. Each individual immune activation marker was quantified as the % of the total population of that particular cellular subset.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants assigned to placebo group
|
Semaglutide
n=54 Participants
Participants assigned to the semaglutide group
|
|---|---|---|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Inflammatory monocytes
|
0.00 % of cell subset
Interval -0.1 to 0.08
|
-0.02 % of cell subset
Interval -0.11 to 0.05
|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Patrolling monocytes
|
-0.01 % of cell subset
Interval -0.04 to 0.02
|
-0.01 % of cell subset
Interval -0.03 to 0.01
|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Activated CD4+ lymphocytes
|
0.92 % of cell subset
Interval -2.44 to 6.47
|
0.07 % of cell subset
Interval -1.93 to 3.91
|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Activated CD8+ lymphocytes
|
0.34 % of cell subset
Interval -1.98 to 3.23
|
-0.63 % of cell subset
Interval -4.95 to 1.17
|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Exhausted CD4+ lymphocytes
|
0.34 % of cell subset
Interval -0.01 to 1.62
|
0.00 % of cell subset
Interval -0.18 to 1.44
|
|
Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline
Exhausted CD8+ lymphocytes
|
4.07 % of cell subset
Interval -4.39 to 11.15
|
2.26 % of cell subset
Interval -9.84 to 7.23
|
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total fat, limb fat, and trunk fat as measured in mass via whole-body DXA scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of pericardial fat as measured in volume by chest CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of pericardial fat as measured by density via chest CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured in density via CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on anthropometric measurements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on lipoprotein profiles and oxidized LDL levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers to assess overall level of systemic inflammation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on cellular markers of inflammation and immune activation markers to assess overall level of systemic immune activation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers by assessing insulin levels, HOMA-IR (calculated based on insulin levels and glucose levels), and timed insulin levels as part of a 4-hour mixed meal tolerance test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut hormones, GIP and GLP-1 levels, by means of a 4-hour mixed-meal tolerance test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut integrity and microbial translocation (e.g., I-FABP, zonulin-1, LPS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on resting energy expenditure by means of indirect calorimetry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on pulse wave velocity, a measure of arterial stiffness, as a surrogate measure of cardiovascular disease risk.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on EndoPat, a measure of endothelial function, as a surrogate measure of cardiovascular disease risk.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 56 weeksSustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on coronary artery calcium (CAC) score as measured by chest CT scan.
Outcome measures
Outcome data not reported
Adverse Events
Participants With HIV and Lipohypertrophy: Semaglutide Arm
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Participants With HIV and Lipohypertrophy: Placebo Arm
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With HIV and Lipohypertrophy: Semaglutide Arm
n=54 participants at risk
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Semaglutide Injectable Product: semaglutide subcutaneous injection
|
Participants With HIV and Lipohypertrophy: Placebo Arm
n=54 participants at risk
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Placebo: placebo injection
|
|---|---|---|
|
Hepatobiliary disorders
Study-Related Serious Adverse Event
|
1.9%
1/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
0.00%
0/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
Other adverse events
| Measure |
Participants With HIV and Lipohypertrophy: Semaglutide Arm
n=54 participants at risk
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Semaglutide Injectable Product: semaglutide subcutaneous injection
|
Participants With HIV and Lipohypertrophy: Placebo Arm
n=54 participants at risk
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Placebo: placebo injection
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Nausea
|
38.9%
21/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
20.4%
11/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
7/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
31.5%
17/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Hepatobiliary disorders
Elevated Total Bilirubin
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
1.9%
1/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Psychiatric disorders
Anxiety or Nervousness
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Bloating or Fullness
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Constipation or Irregular Bowel Movements
|
31.5%
17/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
13.0%
7/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Renal and urinary disorders
Decreased Phosphorus
|
24.1%
13/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
18.5%
10/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Renal and urinary disorders
Decreased Sodium
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
12/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Hepatobiliary disorders
Elevated Alanine Transaminase
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Hepatobiliary disorders
Elevated Aspartate Transferase
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Renal and urinary disorders
Elevated Creatinine
|
46.3%
25/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
25.9%
14/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Endocrine disorders
Elevated Glucose
|
46.3%
25/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
72.2%
39/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Endocrine disorders
Elevated Lipase
|
24.1%
13/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Renal and urinary disorders
Elevated Potassium
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Renal and urinary disorders
Elevated Uric Acid
|
22.2%
12/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
24.1%
13/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Eructation or Flatulence
|
27.8%
15/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
18.5%
10/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Fatigue
|
29.6%
16/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
14.8%
8/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
1.9%
1/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Headaches
|
27.8%
15/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
18.5%
10/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Psychiatric disorders
Irritability or Moodiness
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Musculoskeletal and connective tissue disorders
Localized Musculoskeletal pain, weakness, swelling, or injury
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
13.0%
7/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
9/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Vascular disorders
Elevated Blood Pressure
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
Decreased Appetite or changes in food cravings/tolerance
|
25.9%
14/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
9.3%
5/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Gastrointestinal disorders
GERD
|
29.6%
16/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
13.0%
7/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Musculoskeletal and connective tissue disorders
Elevated Creatine Kinase
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Sweating
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Dizziness
|
11.1%
6/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
7.4%
4/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Cardiac disorders
Elevated Low-density Lipoprotein
|
18.5%
10/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
33.3%
18/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Cardiac disorders
Elevated Total Cholesterol
|
27.8%
15/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
46.3%
25/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
Cardiac disorders
Elevated Triglycerides
|
51.9%
28/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
72.2%
39/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Shakiness
|
3.7%
2/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Hunger
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
18.5%
10/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Dysgeusia
|
13.0%
7/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
|
General disorders
Dry Mouth
|
0.00%
0/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
5.6%
3/54 • Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.
All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly.
|
Additional Information
Allison Ross Eckard, MD
Medical University of South Carolina
Phone: 843-792-4541
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place