DelfaGLP-1 Atlas

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RecruitingPhase 2

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

12

estimated

Study population

HIV, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06935838
Org study IDH064
Secondary IDU54GM138062

Timeline

Milestones

Study first posted2025-04-20actual
Study start2025-11-12actual
Last update posted2026-05-27actual
Primary completion2026-07-31estimated
Study completion2026-07-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

HIVObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Cardiometabolic biomarkers
5
Weight & body composition
3
MASH / liver
2

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change in Baseline Body Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body composition

Time frame:12 weeks

descriptive, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:12 weeks

Waist circumference, change

change from baseline, improvement

MASH / liver

2 endpoints
Secondary/protocol endpoint

Liver fat content

Time frame:12 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Liver stiffness measurement (LSM)

Time frame:12 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Change in Inflammatory Markers: IL-1β

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Inflammatory Markers: TNF-α

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Inflammatory Markers: NFkB

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Inflammatory Markers: sCD163, and sCD14

Time frame:12 weeks

change from baseline, improvement

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Change in Inflammatory Markers: GM-CSF

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in cardiometabolic markers

Time frame:12 weeks

change from baseline, improvement

componentsHbA1c, change, LDL-C, change, HDL-C, change, Triglycerides, change, Total cholesterol, change

Secondary/protocol endpoint/low confidence

Monocyte Subset Analysis

Time frame:Week 12 and week 16

descriptive

Secondary/protocol endpoint/low confidence

Change in Inflammatory Markers: IFN-γ

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Inflammatory Markers: IL-2

Time frame:12 weeks

change from baseline, improvement

Other/protocol endpoint

Biorepository samples for future research

Time frame: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.

descriptive

Publications (13)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.