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RECRUITING
NCT07325500
PHASE2

Incretin Microdosing for Cardiometabolic Health in People With HIV

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-02-12

Completion Date

2029-06-30

Last Updated

2026-02-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dose 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.

DRUG

Dose 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