RecruitingPhase 2NCT07325500

Incretin Microdosing for Cardiometabolic Health in People With HIV

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

30 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The objectives of this study are as follows: Primary Objective * To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy. Secondary Objectives * To evaluate the tolerability of semaglutide microdosing in adults with HIV. * To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether very small doses of incretin medications (like GLP-1 drugs used for type 2 diabetes and weight loss) can improve cardiometabolic health — including heart health, weight, and metabolic markers — in people living with HIV who are overweight or have obesity. People with HIV often have higher rates of heart disease and metabolic problems due to the virus and the medications used to treat it. **You may be eligible if...** - You are living with HIV-1 and have been on stable antiretroviral therapy (ART) for at least 24 weeks - Your HIV viral load is undetectable (below 200 copies/mL) - Your BMI is 30 or higher (or 27+ if you have a weight-related health condition) - Any blood pressure, lipid, or blood sugar medications have been at a stable dose for at least 12 weeks **You may NOT be eligible if...** - You have been diagnosed with diabetes (pre-diabetes on stable metformin is okay) - You weigh 400 pounds or more - You have had bariatric or major stomach surgery - You have active severe gastroparesis (stomach-emptying disorder) - You currently use GLP-1 drugs, weight loss medications, or growth hormone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly

Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60.

DRUGDose escalation to 2 mg semaglutide weekly then no semaglutide

Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT07325500


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