Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07707778

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Body Weight Communicable Diseases Diabetes Mellitus Dyslipidaemia Dyslipidemias Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Insulin Resistance Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Metabolic Dysfunction Associated Steatotic Liver Disease Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospial

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Tirzepatide will be given to the study arm after 8 weeks of diet and nutrition services. Study arm will receive a total of 25 weeks of tirzepatide.

Primary outcomes

  1. Second generation epigenetic aging clock

    Time frame: Baseline, week 33, week 57

    PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years.

  2. Third generation epigenetic aging clock

    Time frame: Baseline, week 33, week 57

    DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year.

Secondary outcomes

  1. Intrahepatic triglycerides

    Time frame: Baseline, week 33, week 57

    Intrahepatic triglycerides will be measured using Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).

  2. Change in body composition assessed by dual-energy X-ray absorptiometry (DXA)

    Time frame: Baseline, week 33, week 57

    Lean body mass and fat mass will be measured in kilograms.

  3. Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA)

    Time frame: Baseline, week 33, week 57

    Bioelectrical impedance analysis will be used to assess fat mass in kilograms.

  4. Patient reported outcome

    Time frame: Baseline, week 33, week 57

    Patient reported outcome will be assessed using HIV symptom index

  5. Drinking habits

    Time frame: Baseline, week 33, week 57

    Alcohol Use Disorders Identification Test (AUDIT) will be used to assess drinking habits for all participants.

  6. Body weight

    Time frame: Baseline, week 8, week 13, week 21, week 33, week 57

    Body weight will be measured in kilograms.

  7. Waist circumference

    Time frame: Baseline, week 8, week 13, week 21, week 33, week 57

    Waist circumference will be measured in centimeters

  8. Inflammation markers

    Time frame: Baseline, week 33, week 57

    C-reactive protein will be measured in mg/dL.

  9. Total bilirubin

    Time frame: Baseline, week 33, week 57

    Total bilirubin will be measured in mg/dL.

  10. Alanine transaminase

    Time frame: Baseline, week 33, week 57

    ALT will be measured in U/L.

  11. Aspartate transminase

    Time frame: Baseline, week 33, week 57

    AST will be measured in U/L.

  12. Fibrosis-4 index

    Time frame: Baseline, week 33, week 57

    Fibrosis-4 index is calculated using AST, ALT, platelet and age.

  13. A1c

    Time frame: Baseline, week 33, week 57

    HbA1c will be measured in percentage.

  14. Fasting plasma glucose

    Time frame: Baseline, week 33, week 57

    Fasting plasma glucose will be measured in mg/dL.

  15. Fasting serum insulin

    Time frame: Baseline, week 33, week 57

    Insulin will be measured in µIU/mL.

  16. Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: Baseline, week 33, week 57

    HOMA-IR will be calculated using fasting insulin and glucose.

  17. Lipid profile

    Time frame: Baseline, week 33, week 57

    Lipid profile includes total cholesterol, HDL, LDL, TG measured in mg/dL.

  18. Creatinine

    Time frame: Baseline, week 33, week 57

    Creatinine will be measured in mg/dL.

  19. NT-proBNP

    Time frame: Baseline, week 33, week 57

    NT-proBNP will be measured in pg/L.

  20. Blood pressure

    Time frame: Baseline, week 8, week 13, week 21, week 33, week 57

    Blood pressure will be measured in millimeter mercury. Both systolic blood pressure and diastolic blood pressure will be measured.

Other outcomes

  1. Bictegravir pharmacokinetics (PK)

    Time frame: Baseline, between week 16-32

    Bictegravir PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels.

  2. Tenofovir pharmacokinetics (PK)

    Time frame: Baseline, between week 16-32.

    Tenofovir PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels

  3. Emtricitabine pharmacokinetics (PK)

    Time frame: Baseline, between week 16-32

    Emtricitabine PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels.

Sponsors and collaborators

Lead sponsor

National Taiwan University Clinical Trial Center

Other

Registry information

Official study title

Reversing the Biological Clock: Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.