Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

ConditionsObesity and Overweight HIV Chronic Inflammation

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Hawaii

About this trial

This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western blot or HIV-1 RNA) AND

HIV-1 RNA <200 copies/mL for ≥ 6 months

BMI ≥27 kg/m2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) OR Obese

BMI ≥ 30 kg/m2

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Tirzepatide
Drug
Tirzepatide is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, obesity and overweight with at least one weight-related medical condition, and moderate to severe obstructive sleep apnea. An initial dose of TZP 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Baseline Body Weight

The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.

Time frame

12 weeks

Secondary outcomes

Change in Inflammatory Markers: GM-CSF

All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: GM-CSF. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.

Time frame

12 weeks

Change in cardiometabolic markers

We will evaluate HbA1c and a lipid profile at the baseline, week 12 and week 16 study visits.

Time frame

12 weeks

Monocyte Subset Analysis

Monocyte subsets will be phenotyped from thawed/washed banked cryopreserved PBMCs (from blood drawn at baseline, week 12, and week 16) using a multiparametric panel of conjugated monoclonal antibodies: CD3, CD14, CD16, CD56, CD19, CD20, HLA-DR antibodies with Live/Dead fixable yellow dead cell stain (YARD). Data will be acquired on a 4-laser BD LSRFortessa Flow Cytometer with all compensation and gating analyses performed with the FlowJo analytical software to determine levels of classical (CD14 ++ CD16 -), intermediate (CD14 ++ CD16 +), non-classical (CD14 + CD16 ++), and transitional (CD14 + CD16 -) monocytes.

Time frame

Week 12 and week 16

Change in Inflammatory Markers: IFN-γ

All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: IFN-γ. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.

Time frame

12 weeks

Other outcomes

Biorepository samples for future research

Obtaining blood specimens for banking in the biorepository for future analyses (frozen for retrospective analysis) related to HIV, cardiometabolic diseases, inflammation and the immune system. Biorespository specimens will be collected at baseline, week 12, week 16 and early discontinuation visits. It will not include genetic testing. The biorepository will enable the development of new hypotheses to further contribute toward understanding of HIV, the immune system, chronic inflammation, and cardiometabolic disease.

Time frame

The biorepository samples (only) will be banked for future analysis for separate research (related or unrelated to this project) for up to 7 years post-study completion.

Sponsors and contacts

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University of Hawaii

Lead sponsor

Source ClinicalTrials.gov

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