Human Immunodeficiency Virus (HIV)Phase 4NCT07707778

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

A Phase 4 study testing Tirzepatide in people with Human Immunodeficiency Virus (HIV) and Metabolic Dysfunction Associated Steatotic Liver Disease, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus (HIV), Metabolic Dysfunction Associated Steatotic Liver Disease, Dyslipidaemia
What is being tested?: Tirzepatide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTaiwan
Study dates: 25 Jun 2026to Dec 2027
Phase: Phase 4

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site

National Taiwan University Hospial
Taipei

Other trials in Taiwan

About this study

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

Conditions: Human Immunodeficiency Virus (HIV), Metabolic Dysfunction Associated Steatotic Liver Disease, Dyslipidaemia, Diabetes Mellitus, Obesity & Overweight, Metabolic Syndrome
Being tested: Tirzepatide
Keywords: tirzepatdie, human immunodeficiency virus, metabolic dysfunction associated steatotic liver disease
Medical subject headings: Acquired Immunodeficiency Syndrome, Dyslipidemias, Diabetes Mellitus, Obesity, Overweight, Metabolic Syndrome

What participants receive

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

TirzepatideDrug
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.

Study groups in NCT07707778
Study group	Role	What they receive
Interventional	Experimental	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. Receives: Drug: Tirzepatide
Standard of care	No intervention	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.

What is being measured

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

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

Secondary outcomes (20)

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

Timeline

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

25 Jun 2026Dec 2027

First posted16 Jul 2026
Study start25 Jun 2026
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07707778
Sponsor's protocol ID: 202604096MINB
Status last verified: Jul 2026
First submitted: 1 Jul 2026
Last updated: 20 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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