LIROH - Liraglutide for Obesity in HIV

What Was Tested

The trial (phase 4) is built around Liraglutide.

Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs.

It had 1 arm (groups): Lirgalutide (experimental).

The registry classes the interventions as drug.

More on the Plan

This elevated risk of obesity in PLWH in South Africa is likely due to a confluence of both general considerations and HIV-specific factors.

First, South Africa has experienced an accelerated background epidemic of metabolic disease in the general population with a prevalence of overweight and obesity that is nearly equal to that of high-income countries.

As part of this background epidemic of metabolic disease, South Africa is also experiencing a nutrition transition, with widespread availability of processed and refined foods as well as sugar-sweetened beverages.

However, this drug class has a very limited evidence base in PLWH and relatively scant data from sub-Saharan African populations.

Who Took Part

The registry lists 40 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: Able to give written informed consent to participate in the study. Able to comply with all study procedures, including daily subcutaneous injections. Adults ≥18 years old. PLWH on dolutegravir-based ART for ≥6 months. Documented HIV-1 viral load in the past 6 months confirming the participant is virologically suppressed.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: known contraindications to liraglutide, such as hypersensitivity to a component of the drug; current pregnancy or desire to become pregnant; history of pancreatitis.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-05-02 with completion listed for 2025-05.

It ran at 1 site in South Africa.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of participants who screen and enroll among those approached (time frame: Measured at screening). Time to reach study enrollment target (time frame: Measured at enrollment). Study retention rate at 12 weeks (time frame: Measured at Visit 4 at 12 weeks).

It also tracked 14 secondary outcomes, for example Incidence of treatment-emergent adverse events as defined in this protocol, Incidence of serious adverse events (SAEs), as defined in this protocol, Change in body weight following 12 weeks on treatment, Change in body weight over 24 weeks (12 weeks on + 12 weeks off treatment), Change in HbA1c following 12 weeks on treatment and Change in HbA1c over 24 weeks (12 weeks on + 12 weeks off treatment).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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