Effects of Semaglutide in HIV-Associated Lipohypertrophy (NCT04019197) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effects of Semaglutide in HIV-Associated Lipohypertrophy
United States108 participantsStarted 2019-05-16
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Timeframe: 32 weeks
2
Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline
Timeframe: 32 weeks
3
Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline
✕. 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.
✕. 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.