LIROH - Liraglutide for Obesity in HIV

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial, called LIROH, is exploring how well a medication called liraglutide can help people living with HIV who are also struggling with obesity. Obesity is defined here as having a body mass index (BMI) of 30 or higher. Participants in the study will receive liraglutide through a daily injection, starting at a low dose and gradually increasing to a higher dose over four weeks. Along with the medication, they will also get guidance on healthy eating and physical activity to support their weight loss journey. The study will last for 24 weeks, with 12 weeks on the medication and 12 weeks after it stops, during which researchers will monitor weight changes, health markers, and how participants feel about their diet, exercise, sleep, and overall quality of life.

To be eligible for the trial, participants need to be at least 18 years old, living with HIV, and on a specific type of treatment for at least six months. They also need to have a BMI of 30 or more and be motivated to lose weight. It's important that they haven't been using any other weight loss medications during the study. Participants will be carefully monitored to ensure their safety and well-being throughout the trial. This research aims to find effective ways to help those living with HIV manage their weight and improve their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to give written informed consent to participate in the study
• • 2. Able to comply with all study procedures, including daily subcutaneous injections
• • 3. Adults ≥18 years old
• • 4. PLWH on dolutegravir-based ART for ≥6 months
• • 5. Documented HIV-1 viral load in the past 6 months confirming the participant is virologically suppressed
• • 6. BMI ≥30 kg/m2
• • 7. Desiring weight loss
• • 8. Willing to undertake lifestyle change
• • 9. Not on any weight loss agent for the duration of the study
• Exclusion Criteria:
• • 1. Self-reported history of diabetes
• • 2. Current use of medications for diabetes
• • 3. Known contraindications to liraglutide, such as hypersensitivity to a component of the drug
• • 4. Current pregnancy or desire to become pregnant
• • 5. History of pancreatitis
• • 6. History of thyroid disease
• • 7. History of harmful use of alcohol
• • 8. Clinically unstable in the opinion of the investigator