Efficacy and Acceptability of Liraglutide for Obesity in People With HIV: Results of an Open-Label Clinical Trial in South Africa

BACKGROUND: In the Liraglutide for Obesity in HIV (LIROH) trial, we evaluated the efficacy and acceptability of liraglutide plus lifestyle counselling on weight and cardiometabolic health markers, along with the effect of discontinuation of therapy, among people with HIV (PWH) and a body mass index (BMI) ≥ 30 kg/m2 in rural South Africa. METHODS: From May - September 2024, we enrolled 40 PWH in KwaZulu-Natal in a Phase IV, open-label clinical trial of liraglutide 3.0 mg daily for 12 weeks. Key cardiometabolic health outcomes included changes in weight, waist circumference, and hemoglobin A1c (HbA1c). We also assessed depression, quality of life (QoL) and sleep quality. We also assessed acceptability of the intervention based on enrollment fraction and retention at 12 weeks and 24 weeks. RESULTS: We screened 52 participants, of whom 44 (85%) were eligible and 40 (91%) consented to enroll. Thirty-eight (95%) completed the study, with 2 (5%) discontinuing treatment due to relocation. Participants experienced substantial reductions in weight and waist circumference, and mean HbA1c (Weight: -2.9% [(-1.0-4.5%]; waist: -5.6 cm [-8.2 to -2.9]; HbA1c: -0.3% [-0.4 to -0.2]). Moreover, depressive symptoms, sleep quality, and psychological QoL all improved significantly with treatment. Weight and waist circumference rebounded significantly off treatment. The changes in depression, sleep quality and QoL were negligible post-treatment. CONCLUSIONS: This trial is among the first studies of GLP-1 RAs in Southern Africa and demonstrates that this class for obesity treatment among PWH in this region has efficacy to improve metabolic health and that the study intervention was acceptable in this population.