Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV

NCTNCT07707778Other id202604096MINB

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Overview

Status: Enrolling by invitation
Phase: Phase 4
Enrollment: 60 participants (estimated)
Sponsor: National Taiwan University Clinical Trial Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
Taiwan
Start: 25 Jun 2026
Primary completion: Dec 2027 (estimated)
Completion: Dec 2027 (estimated)
First posted: 16 Jul 2026
Last update posted: 20 Jul 2026
Conditions: Human Immunodeficiency Virus (HIV) · Metabolic Dysfunction Associated Steatotic Liver Disease · Dyslipidaemia · Diabetes Mellitus · Obesity & Overweight · Metabolic Syndrome

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 4
Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV
NCT07707778
25 Jun 2026 to est. Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is a pilot, open-lable, two-arm study. The investigators will enroll virally suppressed people living with HIV and obesity to evaluate the effect of tirzepatide on epigenetic aging, assessed by DNA methylation-based clocks using peripheral blood. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.

Interventions

TirzepatideDrug

Arms2

Experimental
Interventional
Participants enrolled in the interventional arm will undergo baseline imaging and blood testing, followed by an 8-week diet and nutrition consultation delivered via a smartphone-based application. Participants will then receive tirzepatide treatment for 25 weeks, after which imaging and blood testing will be repeated. Tirzepatide will subsequently be withheld for 24 weeks, with imaging and blood testing repeated once more to assess the persistence of treatment effect. Bictegravir PK/PD study will be done to assess whether tirzepatide will affect bictegravir pharmacokinetics during the study.
No intervention
Standard of care
Participants enrolled in the standard of care arm will undergo identical imaging and blood testing, but without bictegravir PK/PD. They will receive diet and nutrition consult delivered via a smartphone-based application throughout the study course.

Primary outcomes2

Outcomes the sponsor listed as primary.

Second generation epigenetic aging clock
Time frame · Baseline, week 33, week 57
Registry description
PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years.
Third generation epigenetic aging clock
Time frame · Baseline, week 33, week 57
Registry description
DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year.

Secondary outcomes(20)

Intrahepatic triglycerides
Time frame · Baseline, week 33, week 57
Registry description
Intrahepatic triglycerides will be measured using Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).
Change in body composition assessed by dual-energy X-ray absorptiometry (DXA)
Time frame · Baseline, week 33, week 57
Registry description
Lean body mass and fat mass will be measured in kilograms.
Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA)
Time frame · Baseline, week 33, week 57
Registry description
Bioelectrical impedance analysis will be used to assess fat mass in kilograms.
Patient reported outcome
Time frame · Baseline, week 33, week 57
Registry description
Patient reported outcome will be assessed using HIV symptom index
Drinking habits
Time frame · Baseline, week 33, week 57
Registry description
Alcohol Use Disorders Identification Test (AUDIT) will be used to assess drinking habits for all participants.
Body weight
Time frame · Baseline, week 8, week 13, week 21, week 33, week 57
Registry description
Body weight will be measured in kilograms.
Waist circumference
Time frame · Baseline, week 8, week 13, week 21, week 33, week 57
Registry description
Waist circumference will be measured in centimeters
Inflammation markers
Time frame · Baseline, week 33, week 57
Registry description
C-reactive protein will be measured in mg/dL.
Total bilirubin
Time frame · Baseline, week 33, week 57
Registry description
Total bilirubin will be measured in mg/dL.
Alanine transaminase
Time frame · Baseline, week 33, week 57
Registry description
ALT will be measured in U/L.
Aspartate transminase
Time frame · Baseline, week 33, week 57
Registry description
AST will be measured in U/L.
Fibrosis-4 index
Time frame · Baseline, week 33, week 57
Registry description
Fibrosis-4 index is calculated using AST, ALT, platelet and age.
A1c
Time frame · Baseline, week 33, week 57
Registry description
HbA1c will be measured in percentage.
Fasting plasma glucose
Time frame · Baseline, week 33, week 57
Registry description
Fasting plasma glucose will be measured in mg/dL.
Fasting serum insulin
Time frame · Baseline, week 33, week 57
Registry description
Insulin will be measured in µIU/mL.
Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame · Baseline, week 33, week 57
Registry description
HOMA-IR will be calculated using fasting insulin and glucose.
Lipid profile
Time frame · Baseline, week 33, week 57
Registry description
Lipid profile includes total cholesterol, HDL, LDL, TG measured in mg/dL.
Creatinine
Time frame · Baseline, week 33, week 57
Registry description
Creatinine will be measured in mg/dL.
NT-proBNP
Time frame · Baseline, week 33, week 57
Registry description
NT-proBNP will be measured in pg/L.
Blood pressure
Time frame · Baseline, week 8, week 13, week 21, week 33, week 57
Registry description
Blood pressure will be measured in millimeter mercury. Both systolic blood pressure and diastolic blood pressure will be measured.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: \- Adult people living with HIV, who are virally suppressed, defined as plasma HIV viral load is \< 200 copies/mL within 6 months before enrollment. Participants have to have BMI \> 30 kg/m2. Exclusion Criteria: * Participants cannot have undergone treatment with any incretin-based treatment within the past 90 days before enrollment. Participants cannot have any AIDS-defining illnesses, active malignancy, or history of decompensated liver failure. Participants cannot be pregnant. Participants cannot have history of acute pancreatitis or a family history of medullary thyroid cancer.

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