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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
South Africa
Africa Health Research Institute Clinical Trials Unit
RECRUITING
Mtubatuba
Contact Information
Primary
Jennifer Manne-Goehler, MD, ScD
jmanne@bwh.harvard.edu
7542246060
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2025-05
Participants
Target number of participants: 40
Treatments
Experimental: Lirgalutide
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 3.0mg 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov