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

Plain-language guide to NCT06935838: phase 2 interventional trial of Tirzepatide, fat loss, obesity & body recomposition, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06935838
Phase
phase 2
Status
completed
Start
2025-11-12
Completion (planned or actual)
2026-06-02
Participants
12 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Obesity and Overweight; HIV; Chronic Inflammation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide for fat loss, obesity & body recomposition.

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).

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).

It had 1 arm (groups): Tirzepatide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Tirzepatide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-11-12 with completion listed for 2026-06-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Baseline Body Weight (time frame: 12 weeks).

It also tracked 14 secondary outcomes, for example Change in Inflammatory Markers: GM-CSF, Change in cardiometabolic markers, Monocyte Subset Analysis, Change in Inflammatory Markers: IFN-γ, Change in Inflammatory Markers: IL-1β and Change in Inflammatory Markers: IL-2.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 12 people with fat loss, obesity & body recomposition.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Fat loss, obesity & body recomposition research.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.