Current partner codePEPTIDESDE
NCT07707778·Phase 4·INTERVENTIONAL

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

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

60

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Tirzepatide

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.

Timeline

From registration to results.

  1. First posted

    Jul 16, 2026

  2. Study start

    Jun 25, 2026

  3. Primary completion

    Dec 2027

  4. Study completion

    Dec 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

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.

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

Intrahepatic triglycerides

Time frame · Baseline, week 33, week 57

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

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

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

Patient reported outcome

Time frame · Baseline, week 33, week 57

Patient reported outcome will be assessed using HIV symptom index

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.

Body weight

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

Body weight will be measured in kilograms.

Waist circumference

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

Waist circumference will be measured in centimeters

Inflammation markers

Time frame · Baseline, week 33, week 57

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

Total bilirubin

Time frame · Baseline, week 33, week 57

Total bilirubin will be measured in mg/dL.

Alanine transaminase

Time frame · Baseline, week 33, week 57

ALT will be measured in U/L.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Taiwan. Showing up to 24 locations stored in the fast local snapshot.

National Taiwan University Hospial

Taipei, Taiwan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

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