Background
Obesity is a common complication of treated HIV, especially among Black Women. Yet, perceptions of optimal body weight among people living with HIV (PLWH) may influence interest in anti-obesity medical therapies. We conducted a pilot clinical trial to assess the acceptability, tolerability, and preliminary efficacy of liraglutide for obesity management in virologically suppressed PLWH in rural KwaZulu-Natal, South Africa.
Methods
In this open-label, Phase IV trial, single arm clinical trial of liraglutide in PLWH (n=40) in South Africa (NCT06438146), we enrolled people ≥18 years old, virologically suppressed on dolutegravir-based ART for ≥6 months, with a BMI ≥30 kg/m2. We excluded individuals on another weight loss agent and those with a history of diabetes. All participants received liraglutide for 12 weeks, with dose escalation from 0.6mg SC daily to 3.0mg daily over the first 4 weeks, plus diet and exercise counseling. The primary outcome is acceptability, assessed by enrollment fraction and retention at 12 weeks. The secondary outcomes include changes in weight, blood pressure, lipids, HbA1c, and key safety measures. Depressive symptoms are being assessed using the Patient Health Questionnaire-9 (PHQ-9).
Results
We screened 51 PWH from May 5, 2024 to September 17, 2024. Of these, 43 (84%) were eligible and among those, 40 (93%) consented for enrollment. Baseline characteristics of the enrolled population are shown in Table 1. As of September 30, 2024, 12 (30%) had completed treatment, 1 (2%) person had discontinued participation in the study, and 27 (68%) were still on-treatment. Among those who completed treatment, there was a 2.5 kg (95% confidence interval [CI]: 0.98-4.09] decrease in mean body weight [100.9 kg to 98.4 kg, p=0.002]. There have been 26 reports of gastrointestinal side effects (Grade 1-2) in 14/40 participants, 2 of which required a pause in dose escalation, and one injection site reaction (Grade 1) to date. The mean depressive symptom score as assessed by the PHQ-9 decreased by 1.33 (CI: 0.02-2.64) points among those who completed treatment to date [1.75 to 0.42, p=0.023].
Conclusions
These preliminary results indicate that liraglutide is highly acceptable and well-tolerated among PLWH with comorbid obesity in South Africa. The findings demonstrate the potential of anti-obesity medications as a treatment strategy in PLWH and motivate larger trials for efficacy in diverse populations with HIV.
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