Trial Outcomes & Findings for Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study) (NCT NCT04216589)
NCT ID: NCT04216589
Last Updated: 2024-10-01
Results Overview
The absolute change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit.
COMPLETED
PHASE2
51 participants
Measured at pre-entry and Week 24
2024-10-01
Participant Flow
The first participant was enrolled in February 2021. Study enrollment was completed in September 2022 with the enrollment of the last participant. Participants were enrolled from 9 sites in the United States and Brazil.
Participant milestones
| Measure |
Semaglutide
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
Completed Study Treatment
|
48
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Semaglutide
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Incarceration
|
1
|
Baseline Characteristics
All participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
Baseline characteristics by cohort
| Measure |
Semaglutide
n=51 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=51 Participants
|
|
Age, Continuous
|
52 years
n=51 Participants
|
|
Sex/Gender, Customized
Cisgender Male
|
30 Participants
n=51 Participants
|
|
Sex/Gender, Customized
Cisgender Female
|
18 Participants
n=51 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
3 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=51 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=51 Participants
|
|
Intra-Hepatic Triglyceride Content (IHTG)
|
12.7 percent of IHTG content
STANDARD_DEVIATION 6.05 • n=48 Participants • All participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
|
PRIMARY outcome
Timeframe: Measured at pre-entry and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in IHTG (%)
|
-4.24 IHTG %
Interval -5.41 to -3.06
|
SECONDARY outcome
Timeframe: Measured at pre-entry and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The percentage change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit. The percentage change is defined as IHTC % at week 24 minus IHTC % at pre-entry, then divided by IHTC % at pre-entry, then multiplied by 100.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Percent) in IHTG (%)
|
-31.33 Relative change %
Interval -39.04 to -23.62
|
SECONDARY outcome
Timeframe: Measured at Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
Intra-hepatic triglyceride content (%) at Week 24 (\<5% vs. \>=5%). All participants were \>=5% at pre-entry.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Level of IHTG (%)
>=5% IHTG
|
34 participants
|
|
Level of IHTG (%)
<5% IHTG
|
14 participants
|
SECONDARY outcome
Timeframe: Measured through Week 24Population: Analysis was done in the intent-to-treat population. These were all participants who were enrolled to the study.
Premature study treatment discontinuation prior to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=51 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Occurrence of Premature Discontinuation of Study Treatment
Premature discontinuation
|
3 participants
|
|
Occurrence of Premature Discontinuation of Study Treatment
Completed study treatment
|
48 participants
|
SECONDARY outcome
Timeframe: Measured through Week 24Population: Analysis was done in the intent-to-treat population. These were all participants who were enrolled to the study.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Outcome measures
| Measure |
Semaglutide
n=51 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment
Yes
|
2 Participants
|
|
Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment
No
|
49 Participants
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in body mass index from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=49 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Body Mass Index (BMI)
|
-2.77 kg/m^2
Interval -3.36 to -2.17
|
SECONDARY outcome
Timeframe: Measured from Week 0 to Week 12Population: Per-protocol population (N=49)
The absolute change in body mass index from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=49 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Body Mass Index (BMI)
|
-2.15 kg/m^2
Interval -2.55 to -1.75
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in body weight from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Body Weight
|
-7.80 kg
Interval -9.48 to -6.13
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in body weight from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=49 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Body Weight
|
-6.16 kg
Interval -7.3 to -5.03
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in minimum WC from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Minimum Waist Circumference (WC)
|
-6.66 cm
Interval -8.54 to -4.78
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in minimum WC from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Minimum Waist Circumference (WC)
|
-5.53 cm
Interval -7.07 to -3.99
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in HOMA-IR from the study entry (Week 0) visit to the Week 24 visit. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a method used to estimate how well your body responds to insulin. HOMA-IR is caluclated with the following formula: (fasting glucose in mmol/L x fasting insulin in mIU/mL)/22.5 A higher HOMA-IR score indicates a greater likelihood of insulin resistance.
Outcome measures
| Measure |
Semaglutide
n=47 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Insulin Resistance (HOMA-IR)
|
-1.46 uU/ml*mmol/l/22.5
Interval -3.17 to 0.25
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Outcomes not available because fasting insulin data was not collected at Week 12.
The absolute change in HOMA-IR from the study entry (Week 0) visit to the Week 12 visit. HOMA-IR (Homeostatic Model Assessment of Insulin Resistanc) is a method used to estimate how well your body responds to insulin. HOMA-IR is caluclated with the following formula: (fasting glucose in mmol/L x fasting insulin in mIU/mL)/22.5 A higher HOMA-IR score indicates a greater likelihood of insulin resistance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in HbA1c from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Hemoglobin A1C (HbA1c)
|
-0.25 HbA1c %
Interval -0.32 to -0.17
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting glucose from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=48 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Glucose
|
-9.90 mg/dl
Interval -14.7 to -5.09
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting glucose from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=47 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Glucose
|
-8.87 mg/dl
Interval -12.26 to -5.48
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting total cholesterol from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Total Cholesterol
|
-3.98 mg/dl
Interval -10.84 to 2.89
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting total cholesterol from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Total Cholesterol
|
-11.93 mg/dl
Interval -19.79 to -4.08
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting LDL cholesterol from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting LDL Cholesterol
|
-1.04 mg/dl
Interval -7.14 to 5.05
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting LDL cholesterol from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=45 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting LDL Cholesterol
|
-6.91 mg/dl
Interval -13.85 to 0.03
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting HDL cholesterol from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting HDL Cholesterol
|
2.04 mg/dl
Interval -0.02 to 4.11
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting HDL cholesterol from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting HDL Cholesterol
|
-0.78 mg/dl
Interval -2.76 to 1.2
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting triglycerides from the study entry (Week 0) visit to the Week 24 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Triglycerides
|
-26.78 mg/dl
Interval -46.04 to -7.53
|
SECONDARY outcome
Timeframe: Measured at Week 0 and Week 12Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
The absolute change in fasting triglycerides from the study entry (Week 0) visit to the Week 12 visit.
Outcome measures
| Measure |
Semaglutide
n=46 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Change (Absolute) in Fasting Triglycerides
|
-18.65 mg/dl
Interval -33.29 to -4.01
|
SECONDARY outcome
Timeframe: Measured at Weeks 0, 12 and 24Population: Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI.
Metabolic syndrome is defined as having ≥3 of the following: increased minimum WC (\>=40 inches for male sex at birth; \>=35 inches for female sex at birth), increased fasting triglyceride level (\>150 mg/dL or taking lipid-lowering medication), reduced fasting HDL cholesterol (\<40 mg/dL for male sex at birth; \<50 mg/dL for female sex at birth), increased blood pressure (\>=135/85 mmHg or taking BP medication), and increased fasting glucose (\>100 mg/dL or taking glucose-lowering medication).
Outcome measures
| Measure |
Semaglutide
n=49 Participants
All participants received a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Presence of Metabolic Syndrome
Baseline · Metabolic syndrome
|
38 Participants
|
|
Presence of Metabolic Syndrome
Baseline · No metabolic syndrome
|
11 Participants
|
|
Presence of Metabolic Syndrome
Week 12 · Metabolic syndrome
|
25 Participants
|
|
Presence of Metabolic Syndrome
Week 12 · No metabolic syndrome
|
21 Participants
|
|
Presence of Metabolic Syndrome
Week 24 · Metabolic syndrome
|
28 Participants
|
|
Presence of Metabolic Syndrome
Week 24 · No metabolic syndrome
|
19 Participants
|
Adverse Events
Semaglutide
Serious adverse events
| Measure |
Semaglutide
n=51 participants at risk
All participants will receive a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Nervous system disorders
Serotonin syndrome
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
Other adverse events
| Measure |
Semaglutide
n=51 participants at risk
All participants will receive a dose of 0.25 mg of semaglutide weekly starting at study entry, followed by 0.5 mg weekly starting at Week 2, and then 1.0 mg weekly from Weeks 4 through 24.
Semaglutide: Administered subcutaneously
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Nausea
|
5.9%
3/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
2/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
General disorders
Chills
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
General disorders
Fatigue
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood cholesterol increased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood creatinine increased
|
3.9%
2/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood glucose increased
|
3.9%
2/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood phosphorus decreased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood triglycerides increased
|
3.9%
2/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Blood uric acid increased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Creatinine renal clearance decreased
|
11.8%
6/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Creatinine renal clearance increased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Haemoglobin decreased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Lipids increased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Investigations
Platelet count decreased
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Nervous system disorders
Serotonin syndrome
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/51 • From study entry to study completion at Week 48 or premature study discontinuation.
All AEs must be recorded on the eCRFs if any of the following criteria have been met: * All Grade ≥3 AEs * Grade ≥2 laboratory values * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting SAE definition or EAE reporting requirement
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place