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

NCT07707778 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 202604096MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus (HIV); Metabolic Dysfunction Associated Steatotic Liver Disease; Dyslipidaemia; Diabetes Mellitus; Obesity & Overweight; Metabolic Syndrome

Keywords

tirzepatdie; human immunodeficiency virus; metabolic dysfunction associated steatotic liver disease

Outcome Measures

Primary Outcomes (2)

• Second generation epigenetic aging clock

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

  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.

  Baseline, week 33, week 57

Secondary Outcomes (20)

• Intrahepatic triglycerides

  Baseline, week 33, week 57

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

  Baseline, week 33, week 57

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

  Baseline, week 33, week 57

• Patient reported outcome

  Baseline, week 33, week 57

• Drinking habits

  Baseline, week 33, week 57

Other Outcomes (3)

• Bictegravir pharmacokinetics (PK)

  Baseline, between week 16-32

• Tenofovir pharmacokinetics (PK)

  Baseline, between week 16-32.

• Emtricitabine pharmacokinetics (PK)

  Baseline, between week 16-32

Study Arms (2)

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.

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.

Interventions

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Clinical Trial Center: lead

Study Sites (1)

National Taiwan University Hospial

Taipei, Taiwan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Dyslipidemias; Diabetes Mellitus; Obesity; Overweight; Metabolic Syndrome

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Hisn-Yun Sun

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 16, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)