Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

NCT06935838 | Recruiting Phase 2 FDA Drug

• 1 other identifier: H064
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.

Conditions

Obesity and Overweight; HIV; Chronic Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Baseline Body Weight

  The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.

  12 weeks

Secondary Outcomes (14)

• Change in Inflammatory Markers: GM-CSF

  12 weeks

• Change in cardiometabolic markers

  12 weeks

• Monocyte Subset Analysis

  Week 12 and week 16

• Change in Inflammatory Markers: IFN-γ

  12 weeks

• Change in Inflammatory Markers: IL-1β

  12 weeks

Other Outcomes (1)

• Biorepository samples for future research

  The biorepository samples (only) will be banked for future analysis for separate research (related or unrelated to this project) for up to 7 years post-study completion.

Study Arms (1)

Tirzepatide

EXPERIMENTAL

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Tirzepatide is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, obesity and overweight with at least one weight-related medical condition, and moderate to severe obstructive sleep apnea. An initial dose of TZP 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg.

Tirzepatide

Eligibility Criteria

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

Age ≥ 18 years HIV-1 infection (well controlled) * Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western blot or HIV-1 RNA) AND * HIV-1 RNA \<200 copies/mL for ≥ 6 months Stable ART · Receiving a stable antiretroviral regimen for at least 1 year prior to study entry Overweight * BMI ≥27 kg/m2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) OR Obese * BMI ≥ 30 kg/m2

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

John A Burns School of Medicine

Honolulu, Hawaii, 96813, United States

RECRUITING

Related Publications (13)

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MeSH Terms

Conditions

Obesity; Overweight

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Central Study Contacts

HICFA Clinical Coordinator

CONTACT

808-726-0622; tzpstudy@hawaii.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 20, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)