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Delfa

← All trials/NCT04019197

Active not recruitingPhase 2Results posted

Effects of Semaglutide in HIV-Associated Lipohypertrophy

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

-

Actual enrollment

108

Study population

HIV, Obesity / overweight

Eligibility highlights

•BMI ≥25

Primary endpoints

•Visceral fat, change•Total fat mass•Effects of Semaglutide on Quantity of Ectopic Fat

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04019197
Org study IDSTUDY20190121
Secondary IDR01DK121619

Timeline

Milestones

Study start2019-05-16actual
Study first posted2019-07-15actual
Primary completion2024-04-30actual
Results first posted2026-02-17actual
Last update posted2026-05-04actual
Study completion2026-09-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

HIVObesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Male or female, aged ≥18 years.

2. HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.

3. Body mass index ≥25 kg/m2.

4. Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.

5. Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.

6. HIV-1 RNA <400 copies/mL for ≥6 months.

7. Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.

8. Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.

9. Stated willingness to comply with all study procedures and availability for the duration of the study.

10. All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35 mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered of child-bearing potential.

11. Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Patient-reported history of menopause, sterilization, and azoospermia is considered acceptable documentation.

12. All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.

13. Have no plans to alter antiretroviral therapy, or to undergo any weight loss program, formal exercise training or surgery during the study period, or initiate structured/strategic antiretroviral treatment interruptions.

Exclusion criteria

1. Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.

2. Any active or chronic uncontrolled inflammatory condition, infection or cancer.

3. Women who are pregnant or breastfeeding.

4. Women with a positive pregnancy test on enrollment or prior to study drug administration.

5. A clinically-relevant illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.

6. Active gastrointestinal symptom Grade >1 within the last month.

7. Regular use of immunomodulators/agents which could impact inflammation. Regular use of NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid medication allowed unless diagnosed with uncontrolled thyroid disease.

8. Inability to communicate effectively with study personnel.

9. Use of megestrol acetate, testosterone, or any steroid use beyond normal amounts found in the body within 6 months of study, or intend to start.

10. Glomerular filtration rate <50 cc/min/1.73 m2.

11. Hemoglobin <10 g/dL.

12. Elevated lipase level >1.5 upper limit of normal

13. AST AND ALT >2.5x upper limit of normal.

14. Use of growth hormone or growth hormone-releasing hormone in the last year, or intent to start.

15. History of excessive alcohol use (on average 2 or more drinks a day) , pancreatitis, thyroid cancer, or a diagnosis of multiple endocrine neoplasia (MEN) syndrome type 2.

16. History of lactose intolerance or inability to consume milk products will be exclusionary for participation in the mixed-meal tolerance test portion of the study.

Endpoints (98)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
41
Cardiometabolic biomarkers
23
Glycemic / diabetes
14
Other (unclassified)
11
MASH / liver
4
Safety / tolerability / PK
2
Other clinical outcomes
2
Patient-reported / QoL
1

Weight & body composition

41 endpoints
Primary/protocol endpoint

Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline

Time frame:32 weeks

Visceral fat, change

change from baseline, improvement

Primary/protocol endpoint

Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline

Time frame:32 weeks

Total fat mass

change from baseline, improvement

Primary/protocol endpoint

Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Primary/registry result

Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline

Time frame:32 weeks

Visceral fat, change

change from baseline, improvement

Posted result

GroupMedian · cm^295% CI
SemaglutideTotal abdominal adipose tissue, cm^2-51.75-84.10 - -2.20
Subcutaneous abdominal adipose tissue, cm^2-34.65-64.40 - -12.40
Visceral abdominal adipose tissue, cm^2-9.45-25.80 - 3.00
PlaceboTotal abdominal adipose tissue, cm^26.65-18.9 - 42.50
Subcutaneous abdominal adipose tissue, cm^23.90-15.00 - 20.20
Visceral abdominal adipose tissue, cm^22.60-13.60 - 19.60
Β coefficient-72.0795% CI-109.88 - 34.26p<0.0001linear combination of regression coeff.

Effects of Semaglutide on Quantity of Abdominal Total Adipose Tissue, cm\^2

Β coefficient-42.0195% CI-75.49 - -8.52p0.0138linear combination of regression coeff.

Effects of Semaglutide on Quantity of Abdominal Subcutaneous Adipose Tissue, cm\^2

Β coefficient-30.8395% CI-50.13 - -11.51p0.0017linear combination of regression coeff.

Effects of Semaglutide on Quantity of Abdominal Visceral Adipose Tissue, cm\^2

Primary/registry result

Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline

Time frame:32 weeks

Total fat mass

change from baseline, improvement

Posted result

GroupMedian · kg95% CI
SemaglutideTotal Body Fat, kg-4.82-7.25 - -2.44
Total Limb Fat, kg-1.79-3.45 - -1.06
Total Trunk Fat, kg-2.86-4.47 - -1.40
PlaceboTotal Body Fat, kg0.25-2.08 - 2.29
Total Limb Fat, kg-0.14-0.72 - 0.61
Total Trunk Fat, kg0.17-1.22 - 1.27
Β coefficient-0.2195% CI-0.33 - -0.08p0.0009linear combination of regression coeff.

Effects of Semaglutide on Quantity of ln(Total Body Fat, kg)

Β coefficient-0.1995% CI-0.32 - -0.05p0.0065[linear combination of regression coeff.

Effects of Semaglutide on Quantity of ln(Total Limb Fat, kg)

Β coefficient-0.2495% CI-0.37 - -0.11p<0.0001linear combination of regression coeff

Effects of Semaglutide on Quantity of ln(Trunk Fat, kg)

Primary/registry result

Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · mL95% CI
Semaglutide-1.85-17.90 - 11.00
Placebo0.00-10.30 - 10.40
Β coefficient-0.1895% CI-0.41 - 0.05p0.13linear combination of regression coeff.

Effects of Semaglutide on Quantity of ln(Pericardial Fat, mL)

Secondary/protocol endpoint

Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline

Time frame:32 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline

Time frame:32 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

componentsTotal fat mass, Subcutaneous fat, change, Visceral fat, change

Secondary/protocol endpoint

Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline

Time frame:32 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline

Time frame:32 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline

Time frame:32 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline

Time frame:32 weeks

ratio, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat)

Time frame:56 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass

Time frame:56 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral)

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quality of Pericardial Fat

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio)

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Resting Energy Expenditure

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result

Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline

Time frame:32 weeks

Lean mass

change from baseline, improvement

Posted result

GroupMedian · kg95% CI
Semaglutide-2.94-3.89 - -1.49
Placebo-0.17-11.61 - 0.66
Β coefficient-2.9895% CI-6.83 - 0.83p0.13linear combination of regression coeff.

Effects of Semaglutide on Quantity of Lean Body Mass, kg

Secondary/registry result

Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline

Time frame:32 weeks

Lean mass

change from baseline, improvement

Posted result

GroupMedian · cm^295% CI
Semaglutide0.10-1.90 - 1.00
Placebo-0.20-2.70 - 2.10
Β coefficient-0.0595% CI-0.15 - 0.04p0.69[linear combination of regression coeff.

Effects of Semaglutide on Quantity of ln(Total Right Psoas Muscle, cm\^2)

Secondary/registry result

Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · Hounsfield units95% CI
SemaglutideAbdominal total adipose tissue, Hounsfield unit0.40-2.30 - 2.50
Abdominal subcutaneous adipose tissue, Hounsfield unit-34.65-64.40 - -12.40
Abdominal visceral adipose tissue, Hounsfield unit-9.45-25.80 - 3.00
PlaceboAbdominal total adipose tissue, Hounsfield unit6.65-18.90 - 42.50
Abdominal subcutaneous adipose tissue, Hounsfield unit3.90-15.00 - 20.20
Abdominal visceral adipose tissue, Hounsfield unit2.60-13.60 - 19.60
Β coefficient0.52-1.30% CI-1.39 - 2.33p0.58linear combination of regression coeff.

Effects of Semaglutide on Quality of Abdominal Total Adipose Tissue, HU (higher density = higher quality)

Β coefficient-0.1295% CI-2.05 - 1.82p0.90[linear combination of regression coeff.

Effects of Semaglutide on Quality of Abdominal Subcutaneous Adipose Tissue, HU (higher density = higher quality)

Β coefficient3.7095% CI1.25 - 6.15p0.0031linear combination of regression coeff.

Effects of Semaglutide on Quality of Abdominal Visceral Adipose Tissue, HU (less negative = higher quality)

Secondary/registry result

Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · Hounsfield units95% CI
Semaglutide0.20-0.90 - 1.10
Placebo0.00-1.40 - 0.30
Β coefficient0.8095% CI-0.33 - 1.93p0.17linear combination of regression coeff.

Effects of Semaglutide on Quality of Pericardial Fat, HU (higher density = higher quality)

Secondary/registry result

Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · Hounsfield units95% CI
Semaglutide0.10-1.90 - 1.00
Placebo-0.20-2.70 - 2.10
Β coefficient-0.5195% CI-3.02 - 1.99p0.69linear combination of regression coeff.

Effects of Semaglutide on Quality of Total Right Psoas Muscle, HU

Secondary/registry result

Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline

Time frame:32 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupMedian · kg95% CI
Semaglutide-7.82-11.88 - -3.90
Placebo0.16-2.54 - 2.59
Β coefficient-0.1195% CI-0.19 - -0.03p0.0057linear combination of regression coeff.

Effects of Semaglutide on ln(Weight, kg)

Secondary/registry result

Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline

Time frame:32 weeks

BMI, change

change from baseline, improvement

Posted result

GroupMedian · kg/m^295% CI
Semaglutide-2.64-4.00 - -1.37
Placebo-0.02-1.05 - 0.66
Β coefficient-4.1595% CI-6.77 - -1.54p0.0018linear combination of regression coeff.

Effects of Semaglutide on Body Mass Index, kg/m2

Secondary/registry result

Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline

Time frame:32 weeks

Waist circumference, change

change from baseline, improvement

Posted result

GroupMedian · cm95% CI
Semaglutide-4.50-11.17 - -0.50
Placebo0.17-2.33 - 2.67
Β coefficient-9.3295% CI-14.55 - -4.10p<0.0001linear combination of regression coeff.

Effects of Semaglutide on Waist Circumference, cm

Secondary/registry result

Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · ratio95% CI
Semaglutide-0.01-0.04 - 0.02
Placebo-0.01-0.05 - 0.02
Β coefficient-0.0295% CI-0.05 - 0.00p0.0854linear combination of regression coeff.

Effects of Semaglutide on ln(Waist-to-Hip Ratio)

Secondary/registry result

Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat)

Time frame:56 weeks

Total fat mass

change from baseline, improvement

Secondary/registry result

Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result

Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass

Time frame:56 weeks

Lean mass

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral)

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Quality of Pericardial Fat

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result

Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result

Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio)

Time frame:56 weeks

change from baseline, improvement

Glycemic / diabetes

14 endpoints
Secondary/protocol endpoint

Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose

Time frame:32 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose

Time frame:32 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline

Time frame:32 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline

Time frame:32 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline

Time frame:32 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Glucose Metabolism

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance

Time frame:56 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/registry result

Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose

Time frame:32 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupMedian · mg/dL95% CI
Semaglutide0.50-5.00 - 7.00
Placebo0.00-11.00 - 9.00
Β coefficient-0.0495% CI-0.09 - 0.01p0.14linear combination of regression coeff.

Effects of Semaglutide on ln(Fasting Glucose)

Secondary/registry result

Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose

Time frame:32 weeks

Postprandial glucose

change from baseline, improvement

Posted result

GroupMedian · mg/mL95% CI
Semaglutide-11.50-41.50 - 2.00
Placebo-2.00-16.00 - 16.00
Β coefficient-18.0095% CI-34.50 - -1.50p0.0324linear combination of regression coeff.

Effects of Semaglutide on 2-h OGTT Glucose

Secondary/registry result

Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline

Time frame:32 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMedian · % of glycosylated hemoglobin95% CI
Semaglutide-0.20-0.60 - -0.10
Placebo0.10-0.10 - 0.20
Β coefficient-0.4795% CI-0.67 - -0.28p<0.0001linear combination of regression coeff.

Effects of Semaglutide on HbA1C %

Secondary/registry result

Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline

Time frame:32 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupMedian · uIU/mL95% CI
SemaglutideFasting insulin, uIU/mL2.00-3.00 - 7.00
2-h OGTT insulin, uIU/mL4.50-13.50 - 18.50
PlaceboFasting insulin, uIU/mL-1.00-6.00 - 4.00
2-h OGTT insulin, uIU/mL2.00-18.00 - 26.00
Β coefficient0.0295% CI-0.26 - 0.29p0.91linear combination of regression coeff.

Effects of Semaglutide on ln(Fasting Insulin, uIU/mL)

Β coefficient-0.3695% CI-0.76 - 0.05p0.0819linear combination of regression coeff.

Effects of Semaglutide on ln(2-h OGTT Insulin, uIU/mL)

Secondary/registry result

Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline

Time frame:32 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupMedian · index95% CI
SemaglutideFasting HOMA-IR0.33-0.76 - 1.93
2-h OGTT HOMA-IR-0.29-6.94 - 3.98
PlaceboFasting HOMA-IR-0.37-1.58 - 0.86
2-h OGTT HOMA-IR1.30-6.26 - 7.19
Β coefficient-0.0295% CI-0.31 - 0.27p0.89linear combination of regression coeff.

Effects of Semaglutide on ln(Fasting HOMA-IR)

Β coefficient-0.5695% CI-1.05 - -0.07p0.0238linear combination of regression coeff

Effects of Semaglutide on ln(2-h OGTT HOMA-IR)

Secondary/registry result

Sustainability of Effects of Semaglutide on Glucose Metabolism

Time frame:56 weeks

change from baseline, improvement

componentsPostprandial glucose, Fasting glucose, change, HbA1c, change

Secondary/registry result

Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance

Time frame:56 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

4 endpoints
Secondary/protocol endpoint

Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Liver Fat

Time frame:56 weeks

Liver fat content, change

change from baseline, improvement

Secondary/registry result

Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline

Time frame:32 weeks

Liver fat content, change

change from baseline, improvement

Posted result

GroupMedian · Hounsfield unit95% CI
Semaglutide1.27-2.40 - 4.43
Placebo0.39-1.95 - 4.23
Β coefficient3.5595% CI-0.30 - 7.41p0.0702linear combination of regression coeff.

Effects of Semaglutide on Liver Fat, HU (i.e., higher density = less fat)

Secondary/registry result

Sustainability of Effects of Semaglutide on Liver Fat

Time frame:56 weeks

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

23 endpoints
Secondary/protocol endpoint

Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline

Time frame:32 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline

Time frame:32 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Lipoprotein Profiles

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Systemic Inflammation

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Systemic Immune Activation

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sustainability of Effects of Semaglutide on Pulse Wave Velocity

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on EndoPat

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · mg/dL95% CI
SemaglutideTotal cholesterol, mg/dL-12.5-28.00 - -3.00
High-density lipoprotein cholesterol, mg/dL-2.50-6.30 - 2.20
Low-density lipoprotein cholesterol, mg/dL-9.00-21.00 - 0.00
Very low-density lipoprotein cholesterol, mg/dL0.00-7.00 - 3.00
Triglycerides, mg/dL-1.00-33.00 - 14.00
PlaceboTotal cholesterol, mg/dL-10.50-27.00 - 7.00
High-density lipoprotein cholesterol, mg/dL-1.60-5.3 - 3.00
Low-density lipoprotein cholesterol, mg/dL-6.00-20.00 - 7.00
Very low-density lipoprotein cholesterol, mg/dL-2.00-10.00 - 6.00
Triglycerides, mg/dL-13.00-50.00 - 25.00
Β coefficient-7.1795% CI-22.20 - 7.85p0.35linear combination of regression coeff

Effects of Semaglutide on Total Cholesterol, mg/dL

Β coefficient-4.2395% CI-17.72 - 9.25p0.54linear combination of regression coeff.

Effects of Semaglutide on Low-Density Lipoprotein Cholesterol, mg/dL

Β coefficient0.0895% CI-0.01 - 0.17p0.0989linear combination of regression coeff.

Effects of Semaglutide on ln(High-Density Lipoprotein Cholesterol, mg/dL)

Β coefficient-0.2095% CI-0.39 - -0.01p0.0375linear combination of regression coeff

Effects of Semaglutide on ln(Very Low-Density Lipoprotein Cholesterol, mg/dL)

Β coefficient-0.2395% CI-0.43 - -0.03p0.0220linear combination of regression coeff.

Effects of Semaglutide on ln(Triglycerides, mg/dL)

Secondary/registry result

Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline

Time frame:32 weeks

Heart rate, change

change from baseline, improvement

Posted result

GroupMedian · beats/minute95% CI
Semaglutide1.50-9.00 - 10.00
Placebo2.00-6.00 - 8.00
Β coefficient-0.3395% CI-5.39 - 4.73p0.90linear combination of regression coeff.

Effects of Semaglutide on Heart Rate

Secondary/registry result

Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · mmHg95% CI
SemaglutideSystolic blood pressure, mmHg-4.00-15.00 - 7.00
Diastolic blood pressure, mmHg-1.50-7.00 - 2.00
PlaceboSystolic blood pressure, mmHg1.00-7.00 - 9.00
Diastolic blood pressure, mmHg3.50-6.00 - 8.00
Β coefficient-0.0595% CI-0.10 - -0.01p0.0203linear combination of regression coeff

Effects of Semaglutide on Systolic blood pressure

Β coefficient-1.2095% CI-4.67 - 2.26p0.50linear combination of regression coeff

Effects of Semaglutide on diastolic blood pressure

Secondary/registry result

Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · 10-year ASCVD risk estimate %95% CI
Semaglutide-0.30-1.70 - 0.30
Placebo0.40-0.60 - 1.10
Β coefficient-0.3995% CI-0.74 - -0.05p0.0264linear combination of regression coeff.

Effects of Semaglutide on ln(10-Year ASCVD Risk Estimate)

Secondary/registry result

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

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · ng/mL95% CI
SemaglutidesTNFR-I, ng/mL-0.07-0.23 - 0.19
sTNFR-II, ng/mL-0.16-0.70 - 0.35
sCD14, ng/mL-130.83-446.01 - 136.27
sCD163, ng/mL-61.30-162.44 - 35.78
sVCAM-1, ng/mL2.44-94.83 - 81.83
sICAM-1, ng/mL-4.99-36.54 - 33.00
PlacebosTNFR-I, ng/mL-0.06-0.24 - 0.16
sTNFR-II, ng/mL0.07-0.68 - 0.70
sCD14, ng/mL-106.11-364.40 - 296.23
sCD163, ng/mL-15.23-107.35 - 79.16
sVCAM-1, ng/mL-21.21-68.58 - 93.50
sICAM-1, ng/mL-6.85-36.64 - 31.19
Β coefficient-0.0195% CI-0.13 - 0.12p0.91Linear/Median Regression of coeff

Effects of semaglutide on sTNFR-I (ng/mL)

Β coefficient-0.0995% CI-0.23 - 0.05p0.20Linear/Median Regression of coeff

Effects of semaglutide on sTNFR-II (ng/mL)

Β coefficient-0.0795% CI-0.19 - 0.04p0.19Linear/Median Regression of coeff

Effects of semaglutide on sCD14 (ng/mL)

Β coefficient-0.1395% CI-0.26 - 0.001p0.05Linear/Median Regression of coeff

Effects of semaglutide on sCD163 (ng/mL)

Β coefficient0.0195% CI-0.07 - 0.09p0.75Linear/Median Regression of coeff

Effects of semaglutide on sVCAM-1 (ng/mL)

Β coefficient-0.00195% CI-0.10 - 0.09p0.98Linear/Median Regression of coeff

Effects of semaglutide on sICAM-1 (ng/mL)

Secondary/registry result

Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline

Time frame:32 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

GroupMedian · µg/mL95% CI
SemaglutideD-dimer, µg/mL0.05-0.14 - 0.19
hsCRP, µg/mL-1.17-3.09 - 0.15
PlaceboD-dimer, µg/mL0.02-0.12 - 0.14
hsCRP, µg/mL-0.11-1.30 - 2.37
Β coefficient0.1095% CI-0.14 - 0.33p0.41Linear/Median Regression of coeff

Effects of semaglutide on D-dimer (µg/mL)

Β coefficient-0.5195% CI-0.87 - -0.15p0.01Linear/Median Regression of coeff

Effects of semaglutide on hsCRP (µg/mL)

Secondary/registry result

Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · pg/mL95% CI
Semaglutide-0.39-1.62 - 0.30
Placebo-0.25-1.66 - 0.74
Β coefficient-0.2195% CI-0.44 - 0.02p0.07Linear/Median Regression of coeff

Effects of semaglutide on IL-6 (pg/mL)

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Lipoprotein Profiles

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Systemic Inflammation

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result

Sustainability of Effects of Semaglutide on Pulse Wave Velocity

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on EndoPat

Time frame:56 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Safety Analyses

Time frame:32 weeks

Treatment-emergent AEs (any)

descriptive

Secondary/registry result

Safety Analyses

Time frame:32 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

GroupParticipants95% CI
Semaglutide≥1 adverse event54-
Serious study-related adverse events1-
Possibly related adverse events21-
≥1 possibly related or study-related adverse event24-
Adverse events or side-effects leading to premature trial discontinuation4-
Grade 4 elevated lipase (week 14)1-
Grade 1 elevated lipase, gastrointestinal symptoms (week 10)1-
Grade 1 gastrointestinal and systemic symptoms (week 12)1-
Grade 1 memory impairment (week 17)0-
Weight loss (week 17)1-
study-related adverse events: Elevated lipase1-
study-related adverse events: Injection site reactions (all grade 1)4-
possibly-related adverse events- Elevated lipase4-
possibly-related adverse events- Elevated lipase: Grade 12-
possibly-related adverse events-Elevated lipase: Grade 22-
possibly-related adverse events Elevated creatinine1-
possibly-related adverse events- Cholelithiasis2-
possibly-related adverse events- Any gastrointestinal disorder18-
possibly-related adverse events- Nausea6-
possibly-related adverse events- Vomiting1-
possibly-related adverse events- Diarrhoea or loose stools0-
possibly-related adverse events- Abdominal pain1-
possibly-related adverse events- Constipation or irregular bowel movements2-
possibly-related adverse events- Eructation or flatulence5-
possibly-related adverse events- Gastroesophageal reflux disease2-
possibly-related adverse events- Bloating or fullness1-
possibly-related adverse events- Dyspepsia1-
possibly-related adverse events- Gastritis0-
possibly-related adverse events- Decreased appetite or changes in food cravings or tolerance7-
possibly-related adverse events- Fatigue2-
possibly-related adverse events- Dysgeusia3-
possibly-related adverse events- Dizziness0-
possibly-related adverse events- Headache3-
possibly-related adverse events- Anxiety or nervousness0-
possibly-related adverse events- Irritability or moodiness1-
possibly-related adverse events- Sweating2-
possibly-related adverse events- Hunger0-
possibly-related adverse events- Generalized myalgias0-
possibly-related adverse events- Scalp alopecia1-
Not study-related adverse events- Elevated lipase8-
Not study-related adverse events- Elevated lipase: Grade 17-
Not study-related adverse events- Elevated lipase: Grade 21-
Not study-related adverse events- Elevated creatinine24-
Not study-related adverse events- Elevated creatinine: Grade 118-
Not study-related adverse events- Elevated creatinine: Grade 26-
Not study-related adverse events- Elevated creatinine: Grade 30-
Not study-related adverse events- Elevated total bilirubin (all grade 1)6-
Not study-related adverse events- Elevated alanine transaminase5-
Not study-related adverse events- Elevated alanine transaminase: Grade 13-
Not study-related adverse events- Elevated alanine transaminase: Grade 22-
Not study-related adverse events- Elevated aspartate aminotransferase3-
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 13-
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 20-
Not study-related adverse events- Elevated glucose25-
Not study-related adverse events- Elevated glucose: Grade 124-
Not study-related adverse events- Elevated glucose: Grade 21-
Not study-related adverse events- Any gastrointestinal disorder35-
Not study-related adverse events- Nausea15-
Not study-related adverse events- Vomiting8-
Not study-related adverse events- Diarrhoea or loose stools7-
Not study-related adverse events- Abdominal pain4-
Not study-related adverse events- Constipation or irregular bowel movements16-
Not study-related adverse events- Bloating or fullness2-
Not study-related adverse events- Dyspepsia11-
Not study-related adverse events- Eructation or flatulence10-
Not study-related adverse events- Gastritis3-
Not study-related adverse events- Gastroesophageal reflux disease14-
Not study-related adverse events- Decreased appetite or changes in food cravings or tolerance8-
Not study-related adverse events- Fatigue14-
Not study-related adverse events- Dysgeusia4-
Not study-related adverse events- Dizziness6-
Not study-related adverse events- Headache12-
Not study-related adverse events- Anxiety or nervousness5-
Not study-related adverse events- Irritability or moodiness5-
Not study-related adverse events- Sweating2-
Not study-related adverse events- Hunger3-
Not study-related adverse events- Generalized myalgias1-
Not study-related adverse events- Shakiness2-
Not study-related adverse events- Weakness1-
Not study-related adverse events- Light-headedness0-
Not study-related adverse events- Temporary neurosensory alteration1-
Not study-related adverse events- Hiccups1-
Not study-related adverse events- Diabetes1-
Placebo≥1 adverse event53-
Serious study-related adverse events0-
Possibly related adverse events17-
≥1 possibly related or study-related adverse event18-
Adverse events or side-effects leading to premature trial discontinuation1-
Grade 4 elevated lipase (week 14)0-
Grade 1 elevated lipase, gastrointestinal symptoms (week 10)0-
Grade 1 gastrointestinal and systemic symptoms (week 12)0-
Grade 1 memory impairment (week 17)1-
Weight loss (week 17)0-
study-related adverse events: Elevated lipase0-
study-related adverse events: Injection site reactions (all grade 1)2-
possibly-related adverse events- Elevated lipase2-
possibly-related adverse events- Elevated lipase: Grade 12-
possibly-related adverse events-Elevated lipase: Grade 20-
possibly-related adverse events Elevated creatinine1-
possibly-related adverse events- Cholelithiasis0-
possibly-related adverse events- Any gastrointestinal disorder15-
possibly-related adverse events- Nausea4-
possibly-related adverse events- Vomiting0-
possibly-related adverse events- Diarrhoea or loose stools7-
possibly-related adverse events- Abdominal pain2-
possibly-related adverse events- Constipation or irregular bowel movements2-
possibly-related adverse events- Eructation or flatulence4-
possibly-related adverse events- Gastroesophageal reflux disease1-
possibly-related adverse events- Bloating or fullness0-
possibly-related adverse events- Dyspepsia2-
possibly-related adverse events- Gastritis1-
possibly-related adverse events- Decreased appetite or changes in food cravings or tolerance1-
possibly-related adverse events- Fatigue2-
possibly-related adverse events- Dysgeusia2-
possibly-related adverse events- Dizziness3-
possibly-related adverse events- Headache0-
possibly-related adverse events- Anxiety or nervousness1-
possibly-related adverse events- Irritability or moodiness2-
possibly-related adverse events- Sweating3-
possibly-related adverse events- Hunger2-
possibly-related adverse events- Generalized myalgias1-
possibly-related adverse events- Scalp alopecia0-
Not study-related adverse events- Elevated lipase3-
Not study-related adverse events- Elevated lipase: Grade 12-
Not study-related adverse events- Elevated lipase: Grade 21-
Not study-related adverse events- Elevated creatinine13-
Not study-related adverse events- Elevated creatinine: Grade 19-
Not study-related adverse events- Elevated creatinine: Grade 23-
Not study-related adverse events- Elevated creatinine: Grade 31-
Not study-related adverse events- Elevated total bilirubin (all grade 1)1-
Not study-related adverse events- Elevated alanine transaminase6-
Not study-related adverse events- Elevated alanine transaminase: Grade 14-
Not study-related adverse events- Elevated alanine transaminase: Grade 22-
Not study-related adverse events- Elevated aspartate aminotransferase4-
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 13-
Not study-related adverse events- Elevated aspartate aminotransferase: Grade 21-
Not study-related adverse events- Elevated glucose39-
Not study-related adverse events- Elevated glucose: Grade 138-
Not study-related adverse events- Elevated glucose: Grade 21-
Not study-related adverse events- Any gastrointestinal disorder27-
Not study-related adverse events- Nausea7-
Not study-related adverse events- Vomiting3-
Not study-related adverse events- Diarrhoea or loose stools10-
Not study-related adverse events- Abdominal pain1-
Not study-related adverse events- Constipation or irregular bowel movements5-
Not study-related adverse events- Bloating or fullness2-
Not study-related adverse events- Dyspepsia0-
Not study-related adverse events- Eructation or flatulence6-
Not study-related adverse events- Gastritis0-
Not study-related adverse events- Gastroesophageal reflux disease6-
Not study-related adverse events- Decreased appetite or changes in food cravings or tolerance4-
Not study-related adverse events- Fatigue6-
Not study-related adverse events- Dysgeusia1-
Not study-related adverse events- Dizziness1-
Not study-related adverse events- Headache10-
Not study-related adverse events- Anxiety or nervousness2-
Not study-related adverse events- Irritability or moodiness4-
Not study-related adverse events- Sweating3-
Not study-related adverse events- Hunger8-
Not study-related adverse events- Generalized myalgias1-
Not study-related adverse events- Shakiness3-
Not study-related adverse events- Weakness0-
Not study-related adverse events- Light-headedness1-
Not study-related adverse events- Temporary neurosensory alteration0-
Not study-related adverse events- Hiccups0-
Not study-related adverse events- Diabetes2-

Other clinical outcomes

2 endpoints
Secondary/registry result

Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · Kcal95% CI
Semaglutide137.33-240.31 - 388.87
Placebo17.84-286.92 - 386.33
Β coefficient-145.8195% CI-522.28 - 230.66p0.45linear combination of regression coeff

Effects of Semaglutide on dietary intake

Secondary/registry result

Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · minutes per week95% CI
SemaglutideLow intensity, minutes per week-85.71-100.00 - 0.00
Moderate intensity, minutes per week-29.17-50.00 - 50.00
High intensity, minutes per week21.11-32.29 - 100.00
PlaceboLow intensity, minutes per week-75.00-100.00 - 51.14
Moderate intensity, minutes per week-25.00-50.00 - 60.00
High intensity, minutes per week0.00-20.00 - 50.00
Β coefficient42095% CI-1012.24 - 1852.24p0.57linear combination of regression coeff

Effects of semaglutide on physical activity (low intensity, minutes per week)

Β coefficient-42095% CI-1250.71 - 410.71p0.32linear combination of regression coeff

Effects of semaglutide on physical activity (moderate intensity, minutes per week)

Β coefficient0.0095% CI-163.04 - 163.04p1.00linear combination of regression coeff

Effects of semaglutide on physical activity (high intensity, minutes per week)

Other (unclassified)

11 endpoints
Secondary/protocol endpoint/low confidence

Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Gut Hormones

Time frame:56 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Gut Integrity

Time frame:56 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline

Time frame:32 weeks

change from baseline, improvement

Posted result

GroupMedian · % of cell subset95% CI
SemaglutideInflammatory monocytes-0.02-0.11 - 0.05
Patrolling monocytes-0.01-0.03 - 0.01
Activated CD4+ lymphocytes0.07-1.93 - 3.91
Activated CD8+ lymphocytes-0.63-4.95 - 1.17
Exhausted CD4+ lymphocytes0.00-0.18 - 1.44
Exhausted CD8+ lymphocytes2.26-9.84 - 7.23
PlaceboInflammatory monocytes0.00-0.10 - 0.08
Patrolling monocytes-0.01-0.04 - 0.02
Activated CD4+ lymphocytes0.92-2.44 - 6.47
Activated CD8+ lymphocytes0.34-1.98 - 3.23
Exhausted CD4+ lymphocytes0.34-0.01 - 1.62
Exhausted CD8+ lymphocytes4.07-4.39 - 11.15
Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Systemic Immune Activation

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Gut Hormones

Time frame:56 weeks

change from baseline, descriptive

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Gut Integrity

Time frame:56 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Resting Energy Expenditure

Time frame:56 weeks

change from baseline, descriptive

Secondary/registry result/low confidence

Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score

Time frame:56 weeks

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.