LIROH

UnknownPhase 4

LIROH - Liraglutide for Obesity in HIV

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

Lead sponsor

Brigham and Women's Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

HIV, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Proportion of participants who screen and enroll among those approached•Reach study enrollment target•Study retention rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06438146

Org study ID2023P002985

Secondary IDK23DK125162

Timeline

Milestones

Study start2024-05-02actual

Study first posted2024-05-31actual

Last update posted2024-05-31actual

Primary completion2025-05estimated (month precision)

Study completion2025-05estimated (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

HIVObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Other clinical outcomes

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change in body weight following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change in waist circumference following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Change in waist circumference over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change in HbA1c following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting plasma glucose over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints

Other/protocol endpoint

Change in blood pressure following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Change in blood pressure over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

Other/protocol endpoint

Change in lipids following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

Change in lipids over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

7 endpoints

Primary/protocol endpoint

Embedded qualitative interviews regarding the acceptability of liraglutide for obesity management

Time frame:Measured at End of Study at 24 weeks

descriptive

Secondary/protocol endpoint

Change in depressive symptoms following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in depressive symptoms over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

Other/protocol endpoint

Change in quality of life following 12 weeks on treatment per the World Health Organization's Quality of Life Instrument in HIV Infection

Time frame:Measured at Visit 4 at 12 weeks

change from baseline, improvement

Other/protocol endpoint

Change in quality of life over 24 weeks (12 weeks on + 12 weeks off treatment) per the World Health Organization's Quality of Life Instrument in HIV Infection

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

Other/protocol endpoint

Change in sleep quality following 12 weeks on treatment per the Pittsburgh Sleep Quality Index

Time frame:Measured at Visit 4 at 12 weeks

change from baseline, improvement

Other/protocol endpoint

Change in sleep quality over 24 weeks (12 weeks on + 12 weeks off treatment) per the Pittsburgh Sleep Quality Index

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Study retention rate at 12 weeks

Time frame:Measured at Visit 4 at 12 weeks

descriptive

Primary/protocol endpoint

Study retention rate at 24 weeks

Time frame:Measured at End of Study at 24 weeks

descriptive

Primary/protocol endpoint

Rate of adherence to treatment over 12 weeks

Time frame:Measured at Visit 4 at 12 weeks

descriptive

Secondary/protocol endpoint

Incidence of treatment-emergent adverse events as defined in this protocol

Time frame:From the initiation of treatment until the date of a treatment-emergent adverse event, assessed up to 24 weeks.

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of serious adverse events (SAEs), as defined in this protocol

Time frame:From the initiation of treatment until the date of a serious adverse event, assessed up to 24 weeks.

Serious AEs (any)

time to event, event

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint/low confidence

Change in physical activity level following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in physical activity level over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in dietary habits following 12 weeks on treatment

Time frame:Measured at Visit 4 at 12 weeks

change from baseline, improvement

componentsfruit vegetable servings, sugar sweetened beverage intake frequency, fast food intake frequency

Secondary/protocol endpoint/low confidence

Change in dietary habits over 24 weeks (12 weeks on + 12 weeks off treatment)

Time frame:Measured at End of Study at 24 weeks

change from baseline, improvement

componentsfruit vegetable servings, sugar sweetened beverage intake frequency, fast food intake frequency

Other (unclassified)

2 endpoints

Primary/protocol endpoint

Proportion of participants who screen and enroll among those approached

Time frame:Measured at screening

descriptive

Primary/protocol endpoint

Time to reach study enrollment target

Time frame:Measured at enrollment

descriptive

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Weight Gain After HIV Therapy Initiation: Pathophysiology and Implications.
The Journal of clinical endocrinology and metabolism2024 Jan 18PMID37437159doi:10.1210/clinem/dgad411via CT.gov background
Perceptions of Health, Body Size, and Nutritional Risk Factors for Obesity in People with HIV in South Africa.
AIDS and behavior2024 Jan (month)PMID37632604doi:10.1007/s10461-023-04152-7via CT.gov background
Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial.
JAMA2022 Jan 11PMID35015037doi:10.1001/jama.2021.23619via CT.gov background
Linkage to HIV care and hypertension and diabetes control in rural South Africa: Results from the population-based Vukuzazi Study.
PLOS global public health2022 (year)PMID36962629doi:10.1371/journal.pgph.0001221via CT.gov background
Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial.
JAMA2021 Apr 13PMID33625476doi:10.1001/jama.2021.1831via CT.gov background
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial.
The lancet. HIV2020 Oct (month)PMID33010240doi:10.1016/S2352-3018(20)30241-1via CT.gov background
Obesity and Weight Gain in Persons with HIV.
Current HIV/AIDS reports2020 Apr (month)PMID32072466doi:10.1007/s11904-020-00483-5via CT.gov background
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
The New England journal of medicine2019 Aug 29PMID31339677doi:10.1056/NEJMoa1902824via CT.gov background
Cardiovascular risk factors among ART-experienced people with HIV in South Africa.
Journal of the International AIDS Society2019 Apr (month)PMID30990252doi:10.1002/jia2.25274via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.