Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirzepatide.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus (HIV), Metabolic Dysfunction Associated Steatotic Liver Disease, Dyslipidaemia, Diabetes Mellitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reversing the Biological Clock: Tirzepatide's Effects on Epigenetic Aging and Metabolic Restoration in Virally Suppressed People With HIV
Overview
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
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 outcome measures
- Second generation epigenetic aging clock [Time frame: Baseline, week 33, week 57]
- Third generation epigenetic aging clock [Time frame: Baseline, week 33, week 57]
Secondary outcome measures (12)
- Intrahepatic triglycerides [Time frame: Baseline, week 33, week 57]
- Change in body composition assessed by dual-energy X-ray absorptiometry (DXA) [Time frame: Baseline, week 33, week 57]
- Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA) [Time frame: Baseline, week 33, week 57]
- Patient reported outcome [Time frame: Baseline, week 33, week 57]
- Drinking habits [Time frame: Baseline, week 33, week 57]
- Body weight [Time frame: Baseline, week 8, week 13, week 21, week 33, week 57]
- Waist circumference [Time frame: Baseline, week 8, week 13, week 21, week 33, week 57]
- Inflammation markers [Time frame: Baseline, week 33, week 57]
- Total bilirubin [Time frame: Baseline, week 33, week 57]
- Alanine transaminase [Time frame: Baseline, week 33, week 57]
- Aspartate transminase [Time frame: Baseline, week 33, week 57]
- Fibrosis-4 index [Time frame: Baseline, week 33, week 57]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospial — Taipei
Identifiers
NCT: NCT07707778 · 202604096MINB