Actively Recruiting
LIROH - Liraglutide for Obesity in HIV
Led by Brigham and Women's Hospital · Updated on 2024-05-31
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LIROH - Liraglutide for Obesity in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- Living with HIV and on dolutegravir-based ART for at least 6 months
- Documented suppressed HIV-1 viral load in the past 6 months
- Body mass index (BMI) of 30 kg/m2 or higher
- Desire to lose weight
- Willing to undertake lifestyle changes
- Not using any weight loss medication during the study
You will not qualify if you...
- History of diabetes
- Currently using medications for diabetes
- Known allergy or contraindication to liraglutide
- Pregnant or planning to become pregnant
- History of pancreatitis
- History of thyroid disease
- History of harmful alcohol use
- Clinically unstable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Africa Health Research Institute Clinical Trials Unit
Mtubatuba, South Africa, 3935
Actively Recruiting
Research Team
J
Jennifer Manne-Goehler, MD, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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