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REINFORCE

RecruitingPhase 2

Incretin Microdosing for Cardiometabolic Health in People With HIV

Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial

Lead sponsor

The University of Texas Health Science Center, Houston

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

HIV, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Percent weight regain from weeks 12-60 (microdosing period)

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 IDNCT07325500

Org study IDHSC-MS-25-0376

Secondary ID1R01DK142171-01A1

Timeline

Milestones

Study first posted2026-01-08actual

Study start2026-02-12actual

Last update posted2026-02-18actual

Primary completion2028-05-31estimated

Study completion2029-06-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

HIVObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Confirmed human immunodeficiency virus type 1 (HIV-1)

•On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration

•HIV-1 ribonucleic acid (RNA) <200 copies/mL at screening

•BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if also with greater than or equal to 1 weight-related comorbidity

•If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration

•All participants must be willing and able to provide written informed consent and undergo all required study procedures

Exclusion criteria

•Weight greater than or equal to 400 pounds [due to dual X-ray absorptiometry (DXA) machine limitations] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry

•Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded)

•Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period

•Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period

•Active eating disorder

•Use of human growth hormone, tesamorelin or anabolic steroids <12 weeks prior to entry, unless on a stable dose for >24 weeks prior to entry, or plans to start any of these medications while on study

•Active, severe delayed gastric emptying

•Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study

•Known retinopathy

•Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

•Untreated, poorly controlled or previously undiagnosed thyroid disease

•Chronic pancreatitis

•Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA)

•Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) <0.5 or >10 milli-international units per liter (mIU/L) at screening

•Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements

•Pregnancy, nursing or plans for either during the study period

•Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period

•Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator

Endpoints (8)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

7 endpoints

Primary/protocol endpoint

Percent weight regain from weeks 12-60 (microdosing period)

Time frame:from week 12 to week 60

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in weight