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.
Status
Enrolling by invitation
Phase
Phase 4
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study 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. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.
Interventions
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.
Timeline
First posted
Jul 16, 2026
Study start
Jun 25, 2026
Primary completion
Dec 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 20, 2026
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.
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
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
Taiwan. Showing up to 24 locations stored in the fast local snapshot.
National Taiwan University Hospial
Taipei, Taiwan
Publications
No PMID-linked publications were present in this registry snapshot.
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