LIROH - Liraglutide for Obesity in HIV
Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy: a Single-arm Acceptability Study in South Africa
Brigham and Women's Hospital
40 participants
May 2, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this single-arm, open label pilot study is to evaluate liraglutide at the recommended dosage administered subcutaneously + lifestyle counselling for the management of people living with HIV (PLWH) with obesity defined by a BMI ≥30 kg/m2 who are on dolutegravir-based ART. Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0 mg daily. Alongside drug administration, participants will receive lifestyle counselling regarding diet and physical activity. Following completion of a 12-week "on treatment" period, liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment. Body weight, cardiometabolic risk parameters, and a suite of patient-reported outcomes regarding diet, physical activity, sleep, and quality of life will be assessed periodically over the course of the study.
Eligibility
Inclusion Criteria9
- 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
- BMI ≥30 kg/m2
- Desiring weight loss
- Willing to undertake lifestyle change
- Not on any weight loss agent for the duration of the study
Exclusion Criteria8
- Self-reported history of diabetes
- Current use of medications for diabetes
- Known contraindications to liraglutide, such as hypersensitivity to a component of the drug
- Current pregnancy or desire to become pregnant
- History of pancreatitis
- History of thyroid disease
- History of harmful use of alcohol
- Clinically unstable in the opinion of the investigator
Interventions
Dosing regimen: In this study protocol, liraglutide dosing will be implemented as follows: Liraglutide will be started at a dose of 0.6 mg per day. Participants will be taught to use the injection pen and will be observed giving the first injection. The dose will then be increased by 0.6 mg each week to a maximum dosage of 3.0 mg per day at the end of 4 weeks. This corresponds to the following dosing schedule: Week 1: 0.6 mg per day for one week Week 2: 1.2 mg per day for one week Week 3: 1.8 mg per day for one week Week 4: 2.4 mg per day for one week Week 5-12: 3.0 mg per day for 8 weeks Week 13-24: No drug administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06438146