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

NCT06438146 Phase 4 RECRUITING

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.

Details

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	40
Start date	2024-05-02
Completion	2025-05

Conditions

• Obesity
• HIV Infections

Interventions

• Liraglutide

Primary outcomes

• Proportion of participants who screen and enroll among those approached — Measured at screening
  This will be expressed in terms of the proportion of participants who attend screening and enrolment visits among the total number who are approached regarding interest in study participation.
• Time to reach study enrollment target — Measured at enrollment
• Study retention rate at 12 weeks — Measured at Visit 4 at 12 weeks
  This will be expressed as a proportion of participants who remain in the study after the 12 week "on treatment" period among those enrolled.
• Study retention rate at 24 weeks — Measured at End of Study at 24 weeks
  This will be expressed as a proportion of participants who remain in the study after the full 24 weeks of study procedures are completed among those enrolled.
• Rate of adherence to treatment over 12 weeks — Measured at Visit 4 at 12 weeks
  The investigators will assess volume remaining in the injector pens and provide a percentage of doses per participant that remained unused at the end of the 12-week period on treatment.
• Embedded qualitative interviews regarding the acceptability of liraglutide for obesity management — Measured at End of Study at 24 weeks
  This will be open-ended responses to a brief exit interview about acceptability and feasibility.

Countries

South Africa