Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy: a Single-arm Acceptability Study in South Africa
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.
• 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