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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK121619 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV. The primary endpoints will be visceral and ectopic fat changes over the study period. The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.
This study is a phase IIb, randomized, double-blinded, placebo-controlled clinical trial of semaglutide in people with HIV-associated lipohypertrophy. Participants will be recruited from 1 site (Cleveland, OH). The duration of the study will be 56 weeks. The interventional phase will last 32 weeks, followed by a 24-week observational phase to assess the sustainability of the intervention. Participants will be randomized 1:1 to receive semaglutide by subcutaneous injection once weekly for 32 weeks (8-week dose escalation phase followed by full-dose for 24 weeks) or matching placebo. The primary objective of this clinical trial is to determine the efficacy of semaglutide in treating lipohypertrophy among non-diabetic people living with HIV by reducing fat accumulation and ectopic fat deposition, altering adipokine levels, improving endothelial function and arterial stiffness, down-regulating key pro-inflammatory cytokines and immune activation without modifying microbial translocation and gut integrity markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HIV and lipohypertrophy: semaglutide arm | Experimental | 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. |
|
| Participants with HIV and lipohypertrophy: placebo arm | Placebo Comparator | Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Injectable Product | Drug | semaglutide subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline | 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) | 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace A McComsey, MD | Case Western Reserve University | Principal Investigator |
| Allison R Eckard, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41098140 | Derived | Atieh O, Daher J, Abboud M, Wu Q, Sattar A, Baissary J, Koberssy Z, Labbato D, Eckard AR, McComsey GA. Effects of Semaglutide on Cognitive Function in People With HIV: A Randomized, Controlled Trial. Clin Infect Dis. 2026 May 20;82(5):753-761. doi: 10.1093/cid/ciaf577. | |
| 40160348 | Derived | Funderburg NT, Ross Eckard A, Wu Q, Sattar A, Ailstock K, Cummings M, Labbato D, McComsey GA. The Effects of Semaglutide on Inflammation and Immune Activation in HIV-associated Lipohypertrophy. Open Forum Infect Dis. 2025 Mar 20;12(4):ofaf152. doi: 10.1093/ofid/ofaf152. eCollection 2025 Apr. |
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Sharing of data generated by this project is an essential part of our proposed activities and will be carried out to comply with the NIH policy on Sharing Research Data. We wish to make our results available both to the community of scientists interested in HIV infection, immune activation and co-morbidities, as well as to people living with HIV infection. The data generated in this project will be presented at local, national and international conferences and published in peer-reviewed journals in a timely fashion. All final peer-reviewed manuscripts that arise from this project will be submitted to PubMed Central. The PI will work to facilitate any request made for data produced under this proposal upon publication of data, using standard, university-approved material/data transfer agreements.
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after completion of total study and publication
individual requests will be reviewed by study PIs.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline | 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. | absolute changes for primary outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | cm^2 | 32 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study-Related Serious Adverse Event | Hepatobiliary disorders | Systematic Assessment | Grade 4 lipase value in asymptomatic participant with no evidence of pancreatitis on abdominal ultrasound |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
Notably, participants were treated with 1.0 mg semaglutide weekly, the US Food and Drug Administration-approved dose at the time of study initiation. Since then, recommended doses have increased to 2.0 mg and 2.4 mg for type 2 diabetes and weight loss, respectively
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Ross Eckard, MD | Medical University of South Carolina | 843-792-4541 | eckarda@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2024 | Oct 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Drug | placebo injection |
|
|
| Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline |
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. |
| 32 weeks |
| Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline | 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) | 32 weeks |
| Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline | 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) | 32 weeks |
| Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | 32 weeks |
| Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | 32 weeks |
| Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | 32 weeks |
| Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | 32 weeks |
| Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose | 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. | 32 weeks |
| Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose | 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. | 32 weeks |
| Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline | 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) | 32 weeks |
| Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles. | 32 weeks |
| Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs. | 32 weeks |
| Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs. | 32 weeks |
| Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline | 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)] | 32 weeks |
| Safety Analyses | 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. | 32 weeks |
| 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 | 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. | 32 weeks |
| Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline | 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. | 32 weeks |
| Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Liver Fat | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quality of Pericardial Fat | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio) | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Glucose Metabolism | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Lipoprotein Profiles | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Systemic Inflammation | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Systemic Immune Activation | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Gut Hormones | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Gut Integrity | Sustainability 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). | 56 weeks |
| Sustainability of Effects of Semaglutide on Resting Energy Expenditure | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Pulse Wave Velocity | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on EndoPat | Sustainability 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. | 56 weeks |
| Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score | Sustainability 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. | 56 weeks |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| 38964353 | Derived | Eckard AR, Wu Q, Sattar A, Ansari-Gilani K, Labbato D, Foster T, Fletcher AA, Adekunle RO, McComsey GA. Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial. Lancet Diabetes Endocrinol. 2024 Aug;12(8):523-534. doi: 10.1016/S2213-8587(24)00150-5. Epub 2024 Jul 1. |
| Withdrawal by Subject |
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| Incarcerated |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline | 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. | absolute changes for primary outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | kg | 32 weeks |
|
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| Primary | Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline | 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. | absolute changes over 32 weeks in each group | Posted | Median | Inter-Quartile Range | mL | 32 weeks |
|
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| Secondary | Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline | 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) | absolute changes in liver fat (i.e., density) over 32 weeks for each group | Posted | Median | Inter-Quartile Range | Hounsfield unit | 32 weeks |
|
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| Secondary | Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline | 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. | absolute changes in lean body mass over 32 weeks for each group | Posted | Median | Inter-Quartile Range | kg | 32 weeks |
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| Secondary | Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline | 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. | absolute changes in total right psoas muscle in each group | Posted | Median | Inter-Quartile Range | cm^2 | 32 weeks |
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| Secondary | Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline | 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) | absolute changes in quality of abdominal fat for each group | Posted | Median | Inter-Quartile Range | Hounsfield units | 32 weeks |
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| Secondary | Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline | 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) | absolute changes in quality of a total pericardial fat for each group | Posted | Median | Inter-Quartile Range | Hounsfield units | 32 weeks |
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| Secondary | Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline | 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. | absolute changes in right psoas muscle density | Posted | Median | Inter-Quartile Range | Hounsfield units | 32 weeks |
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| Secondary | Effects of Semaglutide on Anthropometric Measurements (Weight) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | kg | 32 weeks |
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| Secondary | Effects of Semaglutide on Anthropometric Measurements (Body Mass Index) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | kg/m^2 | 32 weeks |
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| Secondary | Effects of Semaglutide on Anthropometric Measurements (Waist Circumference) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | cm | 32 weeks |
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| Secondary | Effects of Semaglutide on Anthropometric Measurements (Waist-to-hip Ratio) at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | ratio | 32 weeks |
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| Secondary | Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - Fasting Glucose | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | mg/dL | 32 weeks |
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| Secondary | Effects of Semaglutide on Glucose Metabolism at Week 32 Compared to Baseline - 2-h OGTT Glucose | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | mg/mL | 32 weeks |
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| Secondary | Effects of Semaglutide on Glucose Metabolism (HgA1C%) at Week 32 Compared to Baseline | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | % of glycosylated hemoglobin | 32 weeks |
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| Secondary | Effects of Semaglutide on Insulin Sensitivity/Resistance (Insulin Levels) at Week 32 Compared to Baseline | 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) | absolute changes of outcome variables over 32 weeks for each group | Posted | Median | Inter-Quartile Range | uIU/mL | 32 weeks |
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| Secondary | Effects of Semaglutide on Insulin Sensitivity/Resistance (HOMA-IR) at Week 32 Compared to Baseline | 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. | absolute changes of outcome variables over 32 weeks for each group | Posted | Median | Inter-Quartile Range | index | 32 weeks |
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| Secondary | Effects of Semaglutide on Lipoprotein Profiles at Week 32 Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles. | absolute changes in outcome variable over 32 weeks in each group | Posted | Median | Inter-Quartile Range | mg/dL | 32 weeks |
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| Secondary | Effects of Semaglutide on Vital Signs (Heart Rate) at 32 Weeks Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs. | absolute changes in outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | beats/minute | 32 weeks |
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| Secondary | Effects of Semaglutide on Vital Signs (Blood Pressure) at 32 Weeks Compared to Baseline | Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on vital signs. | absolute changes in outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | mmHg | 32 weeks |
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| Secondary | Effects of Semaglutide on Overall Cardiovascular Disease (CVD) Risk at Week 32 Compared to Baseline | 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. | absolute changes in 10-year ASCVD risk estimate | Posted | Median | Inter-Quartile Range | 10-year ASCVD risk estimate % | 32 weeks |
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| Secondary | Effects of Semaglutide on Dietary Intake at Week 32 Compared to Baseline | 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. | absolute change in Daily estimated total calories, kcal (dietary intake) | Posted | Median | Inter-Quartile Range | Kcal | 32 weeks |
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| Secondary | Effects of Semaglutide on Physical Activity at Week 32 Compared to Baseline | 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)] | absolute changes in estimated weekly physical activity | Posted | Median | Inter-Quartile Range | minutes per week | 32 weeks |
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| Secondary | Safety Analyses | 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. | General adverse event data | Posted | Count of Participants | Participants | 32 weeks |
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| Secondary | 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 | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | ng/mL | 32 weeks |
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| Secondary | Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (D-dimer, hsCRP) at Week 32 Compared to Baseline | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | µg/mL | 32 weeks |
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| Secondary | Effects of Semaglutide on Systemic Inflammation and Soluble Markers of Immune Activation (IL-6) at Week 32 Compared to Baseline | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | pg/mL | 32 weeks |
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| Secondary | Effects of Semaglutide on Systemic Immune Activation (Cellular Markers) at Week 32 Compared to Baseline | 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. | absolute changes for outcomes measures over 32 weeks for each group | Posted | Median | Inter-Quartile Range | % of cell subset | 32 weeks |
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| Secondary | Sustainability of Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quantity of Pericardial Fat | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Liver Fat | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quantity of Lean Body Mass | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quantity of Total Right Psoas Muscle | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quality of Pericardial Fat | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Quality of Total Right Psoas Muscle | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Anthropometric Measurements (Weight, Waist Circumference, Waist-to-hip Ratio) | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Glucose Metabolism | Sustainability 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. | Not Posted | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Lipoprotein Profiles | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Systemic Inflammation | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Systemic Immune Activation | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Insulin Sensitivity/Resistance | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Gut Hormones | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Gut Integrity | Sustainability 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). | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Resting Energy Expenditure | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Pulse Wave Velocity | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on EndoPat | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| Secondary | Sustainability of Effects of Semaglutide on Coronary Artery Calcium (CAC) Score | Sustainability 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. | Not Posted | Sep 2027 | 56 weeks | Participants |
| 0 |
| 54 |
| 1 |
| 54 |
| 53 |
| 54 |
| EG001 | 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 | 0 | 54 | 0 | 54 | 53 | 54 |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Elevated Total Bilirubin | Hepatobiliary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Anxiety or Nervousness | Psychiatric disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Bloating or Fullness | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Constipation or Irregular Bowel Movements | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Decreased Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Decreased Phosphorus | Renal and urinary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
|
| Decreased Sodium | Renal and urinary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Elevated Alanine Transaminase | Hepatobiliary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Aspartate Transferase | Hepatobiliary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Glucose | Endocrine disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Lipase | Endocrine disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Potassium | Renal and urinary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Uric Acid | Renal and urinary disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Eructation or Flatulence | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Fatigue | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Headaches | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Irritability or Moodiness | Psychiatric disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Localized Musculoskeletal pain, weakness, swelling, or injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Elevated Blood Pressure | Vascular disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Decreased Appetite or changes in food cravings/tolerance | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| GERD | Gastrointestinal disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Elevated Creatine Kinase | Musculoskeletal and connective tissue disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Sweating | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Dizziness | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Elevated Low-density Lipoprotein | Cardiac disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
|
| Elevated Total Cholesterol | Cardiac disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Elevated Triglycerides | Cardiac disorders | Systematic Assessment | All collected laboratory values listed in NIAID AE table (corrected version 2.1, 2017) were recorded and reported here if grade 1 threshold or higher and frequency exceeded 5% for either arm after entry to week 32, regardless of relationship to study |
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| Shakiness | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Hunger | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Dysgeusia | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
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| Dry Mouth | General disorders | Systematic Assessment | AE reported by participant(s) at any time after entry to week 32 were recorded and reported here if frequency exceeded 5% for either arm, regardless of relationship to study |
|
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Total Trunk Fat, kg |
|
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on Quantity of ln(Total Limb Fat, kg) | [linear combination of regression coeff. | 0.0065 | β coefficient | -0.19 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.32 | -0.05 | Estimated % change = -17.3% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on Quantity of ln(Trunk Fat, kg) | linear combination of regression coeff | <0.0001 | β coefficient | -0.24 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.37 | -0.11 | Estimated % change = -18.9% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Abdominal visceral adipose tissue, Hounsfield unit |
|
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on Quality of Abdominal Subcutaneous Adipose Tissue, HU (higher density = higher quality) | [linear combination of regression coeff. | 0.90 | β coefficient | -0.12 | Standard Error of the Mean | 0.93 | 2-Sided | 95 | -2.05 | 1.82 | Estimated % change = 0.10% (calculated from the final fitted model using the formulas 100(β/regression intercept)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on Quality of Abdominal Visceral Adipose Tissue, HU (less negative = higher quality) | linear combination of regression coeff. | β coefficient | 0.0031 | β coefficient | 3.70 | Standard Error of the Mean | 1.25 | 2-Sided | 95 | 1.25 | 6.15 | Estimated % change = -4.4% (calculated from the final fitted model using the formulas 100(β/regression intercept)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of Semaglutide on ln(2-h OGTT Insulin, uIU/mL) | linear combination of regression coeff. | 0.0819 | β coefficient | -0.36 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.76 | 0.05 | Estimated % change = -30.1% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on ln(2-h OGTT HOMA-IR) | linear combination of regression coeff | 0.0238 | β coefficient | -0.56 | Standard Error of the Mean | 0.25 | 2-Sided | 95 | -1.05 | -0.07 | Estimated % change = -43.0% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Low-density lipoprotein cholesterol, mg/dL |
|
| Very low-density lipoprotein cholesterol, mg/dL |
|
| Triglycerides, mg/dL |
|
| Effects of Semaglutide on Low-Density Lipoprotein Cholesterol, mg/dL | linear combination of regression coeff. | 0.54 | β coefficient | -4.23 | Standard Error of the Mean | 6.88 | 2-Sided | 95 | -17.72 | 9.25 | Estimated % change = -3.7% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of Semaglutide on ln(High-Density Lipoprotein Cholesterol, mg/dL) | linear combination of regression coeff. | 0.0989 | β coefficient | 0.08 | Standard Error of the Mean | 0.05 | 2-Sided | 95 | -0.01 | 0.17 | Estimated % change = -8.1% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of Semaglutide on ln(Very Low-Density Lipoprotein Cholesterol, mg/dL) | linear combination of regression coeff | 0.0375 | β coefficient | -0.20 | Standard Error of the Mean | 0.10 | 2-Sided | 95 | -0.39 | -0.01 | Estimated % change = -18.0% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of Semaglutide on ln(Triglycerides, mg/dL) | linear combination of regression coeff. | 0.0220 | β coefficient | -0.23 | Standard Error of the Mean | 0.10 | 2-Sided | 95 | -0.43 | -0.03 | Estimated % change = -20.7% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| Effects of Semaglutide on diastolic blood pressure | linear combination of regression coeff | 0.50 | β coefficient | -1.20 | Standard Error of the Mean | 1.77 | 2-Sided | 95 | -4.67 | 2.26 | Estimated % change = -1.5% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989. |
| High intensity, minutes per week |
|
Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of semaglutide on physical activity (moderate intensity, minutes per week) | linear combination of regression coeff | 0.32 | β coefficient | -420 | Standard Error of the Mean | 423.84 | 2-Sided | 95 | -1250.71 | 410.71 | Estimated % change = -16.7% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Effects of semaglutide on physical activity (high intensity, minutes per week) | linear combination of regression coeff | 1.00 | β coefficient | 0.00 | Standard Error of the Mean | 83.19 | 2-Sided | 95 | -163.04 | 163.04 | Estimated % change = 0.0% (calculated from the final fitted model using the formula 100(eβ-1)) | Other | Generalized estimating equations and appropriate linear combination of regression coefficients were used to model the effects of semaglutide on outcome variables. β coefficient from the final fitted linear combination of regression coefficients model estimates the effect size of semaglutide at the 32-week timepoint on the outcome measure, adjusted for sex and multiplicative effects of treatment and time. Ln-transformation was applied before forming GEE model due to skewed distribution of data. | Benjamini-Hochberg analysis was applied to the variable with a false discovery rate 0.20 correction to determine whether p value showed statistical significance in the presence of the other variables; p-value cut-off for statistical significance in this model was at or below 0.0989 |
| Possibly related adverse events |
|
| ≥1 possibly related or study-related adverse event |
|
| Adverse events or side-effects leading to premature trial discontinuation |
|
| Grade 4 elevated lipase (week 14) |
|
| Grade 1 elevated lipase, gastrointestinal symptoms (week 10) |
|
| Grade 1 gastrointestinal and systemic symptoms (week 12) |
|
| Grade 1 memory impairment (week 17) |
|
| Weight loss (week 17) |
|
| study-related adverse events: Elevated lipase |
|
| study-related adverse events: Injection site reactions (all grade 1) |
|
| possibly-related adverse events- Elevated lipase |
|
| possibly-related adverse events- Elevated lipase: Grade 1 |
|
| possibly-related adverse events-Elevated lipase: Grade 2 |
|
| possibly-related adverse events Elevated creatinine |
|
| possibly-related adverse events- Cholelithiasis |
|
| possibly-related adverse events- Any gastrointestinal disorder |
|
| possibly-related adverse events- Nausea |
|
| possibly-related adverse events- Vomiting |
|
| possibly-related adverse events- Diarrhoea or loose stools |
|
| possibly-related adverse events- Abdominal pain |
|
| possibly-related adverse events- Constipation or irregular bowel movements |
|
| possibly-related adverse events- Eructation or flatulence |
|
| possibly-related adverse events- Gastroesophageal reflux disease |
|
| possibly-related adverse events- Bloating or fullness |
|
| possibly-related adverse events- Dyspepsia |
|
| possibly-related adverse events- Gastritis |
|
| possibly-related adverse events- Decreased appetite or changes in food cravings or tolerance |
|
| possibly-related adverse events- Fatigue |
|
| possibly-related adverse events- Dysgeusia |
|
| possibly-related adverse events- Dizziness |
|
| possibly-related adverse events- Headache |
|
| possibly-related adverse events- Anxiety or nervousness |
|
| possibly-related adverse events- Irritability or moodiness |
|
| possibly-related adverse events- Sweating |
|
| possibly-related adverse events- Hunger |
|
| possibly-related adverse events- Generalized myalgias |
|
| possibly-related adverse events- Scalp alopecia |
|
| Not study-related adverse events- Elevated lipase |
|
| Not study-related adverse events- Elevated lipase: Grade 1 |
|
| Not study-related adverse events- Elevated lipase: Grade 2 |
|
| Not study-related adverse events- Elevated creatinine |
|
| Not study-related adverse events- Elevated creatinine: Grade 1 |
|
| Not study-related adverse events- Elevated creatinine: Grade 2 |
|
| Not study-related adverse events- Elevated creatinine: Grade 3 |
|
| Not study-related adverse events- Elevated total bilirubin (all grade 1) |
|
| Not study-related adverse events- Elevated alanine transaminase |
|
| Not study-related adverse events- Elevated alanine transaminase: Grade 1 |
|
| Not study-related adverse events- Elevated alanine transaminase: Grade 2 |
|
| Not study-related adverse events- Elevated aspartate aminotransferase |
|
| Not study-related adverse events- Elevated aspartate aminotransferase: Grade 1 |
|
| Not study-related adverse events- Elevated aspartate aminotransferase: Grade 2 |
|
| Not study-related adverse events- Elevated glucose |
|
| Not study-related adverse events- Elevated glucose: Grade 1 |
|
| Not study-related adverse events- Elevated glucose: Grade 2 |
|
| Not study-related adverse events- Any gastrointestinal disorder |
|
| Not study-related adverse events- Nausea |
|
| Not study-related adverse events- Vomiting |
|
| Not study-related adverse events- Diarrhoea or loose stools |
|
| Not study-related adverse events- Abdominal pain |
|
| Not study-related adverse events- Constipation or irregular bowel movements |
|
| Not study-related adverse events- Bloating or fullness |
|
| Not study-related adverse events- Dyspepsia |
|
| Not study-related adverse events- Eructation or flatulence |
|
| Not study-related adverse events- Gastritis |
|
| Not study-related adverse events- Gastroesophageal reflux disease |
|
| Not study-related adverse events- Decreased appetite or changes in food cravings or tolerance |
|
| Not study-related adverse events- Fatigue |
|
| Not study-related adverse events- Dysgeusia |
|
| Not study-related adverse events- Dizziness |
|
| Not study-related adverse events- Headache |
|
| Not study-related adverse events- Anxiety or nervousness |
|
| Not study-related adverse events- Irritability or moodiness |
|
| Not study-related adverse events- Sweating |
|
| Not study-related adverse events- Hunger |
|
| Not study-related adverse events- Generalized myalgias |
|
| Not study-related adverse events- Shakiness |
|
| Not study-related adverse events- Weakness |
|
| Not study-related adverse events- Light-headedness |
|
| Not study-related adverse events- Temporary neurosensory alteration |
|
| Not study-related adverse events- Hiccups |
|
| Not study-related adverse events- Diabetes |
|
| sCD14, ng/mL |
|
| sCD163, ng/mL |
|
| sVCAM-1, ng/mL |
|
| sICAM-1, ng/mL |
|
Estimated % change = -0.70 |
| Effects of semaglutide on sTNFR-II (ng/mL) | Linear/Median Regression of coeff | 0.20 | β coefficient | -0.09 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.23 | 0.05 | Estimated % change = -8.71 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Effects of semaglutide on sCD14 (ng/mL) | Linear/Median Regression of coeff | 0.19 | β coefficient | -0.07 | Standard Error of the Mean | 0.06 | 2-Sided | 95 | -0.19 | 0.04 | Estimated % change = -7.22 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Effects of semaglutide on sCD163 (ng/mL) | Linear/Median Regression of coeff | 0.05 | β coefficient | -0.13 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.26 | 0.001 | Estimated % change = -12.10 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Effects of semaglutide on sVCAM-1 (ng/mL) | Linear/Median Regression of coeff | 0.75 | β coefficient | 0.01 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | -0.07 | 0.09 | Estimated % change = 1.28 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Effects of semaglutide on sICAM-1 (ng/mL) | Linear/Median Regression of coeff | 0.98 | β coefficient | -0.001 | Standard Error of the Mean | 0.05 | 2-Sided | 95 | -0.10 | 0.09 | Estimated % change = -0.14 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Effects of semaglutide on hsCRP (µg/mL) | Linear/Median Regression of coeff | 0.01 | β coefficient | -0.51 | Standard Error of the Mean | 0.18 | 2-Sided | 95 | -0.87 | -0.15 | Estimated % change = -39.92 | Other | Depending on the data distribution, either linear regression or quantile (median) regression models were used to estimate the effect of semaglutide on the outcome variables or biomarkers. Because of the differences in biomarkers at baseline, we controlled for heterogeneities by adding baseline values of the outcome variables as covariates. We also controlled for known confounding covariates such as age, sex, and smoking status in the regression analyses. |
| Activated CD4+ lymphocytes |
|
| Activated CD8+ lymphocytes |
|
| Exhausted CD4+ lymphocytes |
|
| Exhausted CD8+ lymphocytes |
|