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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.