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AzTrials

HIV/AIDSPhase 2NCT04019197

Effects of Semaglutide in HIV-Associated Lipohypertrophy

A Phase 2 study testing Semaglutide Injectable Product in people with HIV/AIDS and Lipohypertrophy, run by Case Western Reserve University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV/AIDS, Lipohypertrophy, Obesity
What is being tested?
Semaglutide Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
2 sitesUnited States
Study dates
16 May 2019to 9 Oct 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥18 years.
  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
  • Body mass index ≥25 kg/m2.
  • Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.
  • Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.
  • HIV-1 RNA <400 copies/mL for ≥6 months.
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  • Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.
  • Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35 mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered of child-bearing potential.
  • Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Patient-reported history of menopause, sterilization, and azoospermia is considered acceptable documentation.
  • All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.
  • Have no plans to alter antiretroviral therapy, or to undergo any weight loss program, formal exercise training or surgery during the study period, or initiate structured/strategic antiretroviral treatment interruptions.

Who cannot join

  • Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.
  • Any active or chronic uncontrolled inflammatory condition, infection or cancer.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • A clinically-relevant illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
  • Active gastrointestinal symptom Grade >1 within the last month.
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  • Regular use of immunomodulators/agents which could impact inflammation. Regular use of NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid medication allowed unless diagnosed with uncontrolled thyroid disease.
  • Inability to communicate effectively with study personnel.
  • Use of megestrol acetate, testosterone, or any steroid use beyond normal amounts found in the body within 6 months of study, or intend to start.
  • Glomerular filtration rate <50 cc/min/1.73 m2.
  • Hemoglobin <10 g/dL.
  • Elevated lipase level >1.5 upper limit of normal
  • AST AND ALT >2.5x upper limit of normal.
  • Use of growth hormone or growth hormone-releasing hormone in the last year, or intent to start.
  • History of excessive alcohol use (on average 2 or more drinks a day) , pancreatitis, thyroid cancer, or a diagnosis of multiple endocrine neoplasia (MEN) syndrome type 2.
  • History of lactose intolerance or inability to consume milk products will be exclusionary for participation in the mixed-meal tolerance test portion of the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Semaglutide Injectable Product, Placebo
Keywords
HIV, lipohypertrophy, semaglutide, GLP-1 receptor agonist, obesity
Medical subject headings
Acquired Immunodeficiency Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Injectable ProductDrug

    Also called semaglutide, Ozempic

    semaglutide subcutaneous injection

  • PlaceboDrug

    Also called placebo injection, placebos

    placebo injection

Study groups in NCT04019197
Study groupRoleWhat they receive
Participants with HIV and lipohypertrophy: semaglutide armExperimentalParticipants 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.
Receives: Drug: Semaglutide Injectable Product
Participants with HIV and lipohypertrophy: placebo armPlacebo comparatorParticipants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 32 weeks

  2. 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.

    Measured: 32 weeks

  3. 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.

    Measured: 32 weeks

Secondary outcomes (46)

  1. 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)

    Measured: 32 weeks

  2. 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.

    Measured: 32 weeks

  3. 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.

    Measured: 32 weeks

  4. 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)

    Measured: 32 weeks

  5. 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)

    Measured: 32 weeks

  6. 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.

    Measured: 32 weeks

  7. 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.

    Measured: 32 weeks

  8. 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.

    Measured: 32 weeks

  9. 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.

    Measured: 32 weeks

  10. 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.

    Measured: 32 weeks

  11. 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.

    Measured: 32 weeks

  12. 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.

    Measured: 32 weeks

  13. 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.

    Measured: 32 weeks

  14. 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)

    Measured: 32 weeks

  15. 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.

    Measured: 32 weeks

  16. 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.

    Measured: 32 weeks

  17. 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.

    Measured: 32 weeks

  18. 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.

    Measured: 32 weeks

  19. 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.

    Measured: 32 weeks

  20. 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.

    Measured: 32 weeks

  21. 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)]

    Measured: 32 weeks

  22. 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.

    Measured: 32 weeks

  23. 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.

    Measured: 32 weeks

  24. 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.

    Measured: 32 weeks

  25. 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.

    Measured: 32 weeks

  26. 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.

    Measured: 32 weeks

  27. 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.

    Measured: 56 weeks

  28. 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.

    Measured: 56 weeks

  29. 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.

    Measured: 56 weeks

  30. 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.

    Measured: 56 weeks

  31. 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.

    Measured: 56 weeks

  32. 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.

    Measured: 56 weeks

  33. 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.

    Measured: 56 weeks

  34. 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.

    Measured: 56 weeks

  35. 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.

    Measured: 56 weeks

  36. 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.

    Measured: 56 weeks

  37. 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.

    Measured: 56 weeks

  38. 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.

    Measured: 56 weeks

  39. 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.

    Measured: 56 weeks

  40. 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.

    Measured: 56 weeks

  41. 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.

    Measured: 56 weeks

  42. 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).

    Measured: 56 weeks

  43. 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.

    Measured: 56 weeks

  44. 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.

    Measured: 56 weeks

  45. 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.

    Measured: 56 weeks

  46. 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.

    Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start16 May 2019
  3. Primary completion30 Apr 2024
  4. Study completion9 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019197
Sponsor's protocol ID
STUDY20190121
Other IDs
R01DK121619
Status last verified
Oct 2026
First submitted
1 Jul 2019
Last updated
27 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Adekunle RO, Wu Q, Sattar A, Ansari-Gilani K, Labbato D, Fletcher AA, McComsey AD, Eckard AR. Durability of Semaglutide Effects After Treatment Discontinuation in HIV-Associated Lipohypertrophy: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Clinical Trial. Open Forum Infect Dis. 2026 Oct 5;13(10):ofag631. doi: 10.1093/ofid/ofag631. eCollection 2026 Oct.

    PubMed 42921178

  • Daher J, Koberssy Z, Moussallem N, Wu Q, Sattar A, Fletcher AA, McComsey CM, Funderburg NT, Ailstock K, Eckard AR. Effects of semaglutide on subclinical cardiovascular health in people with HIV. AIDS. 2026 Sep 17. doi: 10.1097/QAD.0000000000004624. Online ahead of print.

    PubMed 42752515

  • 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.

    PubMed 41098140

  • 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.

    PubMed 40160348

  • 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.

    PubMed 38964353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide Injectable Product in people with HIV/AIDS and Lipohypertrophy, run by Case Western Reserve University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline (time frame: 32 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019197, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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