Incretin Microdosing for Cardiometabolic Health in People With HIV

What Was Tested

The trial (phase 2) is built around Semaglutide.

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.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 planned participants were the target.

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: Confirmed human immunodeficiency virus type 1 (HIV-1). 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. All participants must be willing and able to provide written informed consent and undergo all required study procedures.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: 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; active, severe delayed gastric emptying.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-02-12 with completion listed for 2028-05-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent weight regain from weeks 12-60 (microdosing period) (time frame: from week 12 to week 60).

It also tracked 7 secondary outcomes, for example Absolute change in weight, Percent change in weight, Absolute change in body mass index (BMI), Percent change in body mass index (BMI), Absolute change in minimum waist circumference and Percent change in minimum waist circumference.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 30 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.