Using liraglutide to help manage obesity in people living with HIV
Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy: a Single-arm Acceptability Study in South Africa
This study is testing if the medication liraglutide, along with lifestyle counseling, can help people living with HIV manage their weight better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Mtubatuba) |
| Trial ID | NCT06438146 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of liraglutide, a medication administered subcutaneously, combined with lifestyle counseling for managing obesity in individuals living with HIV who are on dolutegravir-based antiretroviral therapy. Participants will gradually increase their liraglutide dosage over four weeks, followed by a 12-week treatment period where their weight and cardiometabolic health will be monitored. After treatment, participants will be followed for an additional 12 weeks to assess the long-term effects of the intervention. The study aims to address the growing obesity epidemic among people living with HIV in South Africa.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older living with HIV, on dolutegravir-based ART for at least six months, with a BMI of 30 kg/m2 or higher, who are motivated to lose weight.
Not a fit: Patients with a history of diabetes, those currently using diabetes medications, or individuals with contraindications to liraglutide will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve weight management and overall health outcomes for individuals living with HIV and obesity.
How similar studies have performed: Other studies have shown promising results using liraglutide for weight management, particularly in populations with obesity, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to give written informed consent to participate in the study 2. Able to comply with all study procedures, including daily subcutaneous injections 3. Adults ≥18 years old 4. PLWH on dolutegravir-based ART for ≥6 months 5. Documented HIV-1 viral load in the past 6 months confirming the participant is virologically suppressed 6. BMI ≥30 kg/m2 7. Desiring weight loss 8. Willing to undertake lifestyle change 9. Not on any weight loss agent for the duration of the study Exclusion Criteria: 1. Self-reported history of diabetes 2. Current use of medications for diabetes 3. Known contraindications to liraglutide, such as hypersensitivity to a component of the drug 4. Current pregnancy or desire to become pregnant 5. History of pancreatitis 6. History of thyroid disease 7. History of harmful use of alcohol 8. Clinically unstable in the opinion of the investigator
Where this trial is running
Mtubatuba
- Africa Health Research Institute Clinical Trials Unit — Mtubatuba, South Africa (Recruiting)
Study contacts
- Principal investigator: Jennifer Manne-Goehler, MD, ScD — Brigham and Women's Hospital
- Study coordinator: Jennifer Manne-Goehler, MD, ScD
- Email: jmanne@bwh.harvard.edu
- Phone: 7542246060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.