DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02743598

TerminatedPhase 4

Liraglutide for HIV-associated Neurocognitive Disorder

Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.

Lead sponsor

Temple University

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

4

actual

Study population

HIV, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 27-45

Primary endpoints

•Neurocognitive performance- change in global cognitive scores on a standard•Neurocognitive performance- change in domain averages on a standard

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 IDNCT02743598
Org study ID23284

Timeline

Milestones

Study first posted2016-04-19estimated
Primary completion2018-06-01actual
Last update posted2022-07-29actual
Study start2016-09actual (month precision)
Study completion2018-09actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

HIVObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•HIV controlled on therapy for at least 12 weeks
•Viral load < 200 copies
•BMI >27 to 45
•Diagnosis of DM type 2 with A1-C >7 to 15
•Participants must be willing to comply with all study related procedures

Exclusion criteria

•Personal or family history of pancreatitis
•Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
•Gastroparesis
•Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
•Weight loss drugs other than metformin
•Type 1 diabetes mellitus or diabetic ketoacidosis
•Known major cognitive deficit dementia, history of head trauma with loss of consciousness >30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
•Renal insufficiency defined as creatinine clearance < 60 mL/min
•Active opportunistic infections
•Pregnancy or breastfeeding
•Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
•Decompensated heart failure
•Substance abuse
•Active alcohol or opioid substitution therapy
•Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation

Endpoints (18)

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

Cardiometabolic biomarkers
6
Weight & body composition
3
Glycemic / diabetes
3
Safety / tolerability / PK
2
Other clinical outcomes
2
MASH / liver
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change from baseline BMI

Time frame:3 and 6 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline weight

Time frame:3 and 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline waist circumference

Time frame:3 and 6 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin

Time frame:3 and 6 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline Hemoglobin A1c

Time frame:3 and 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline fructosamine

Time frame:3 and 6 months

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase

Time frame:3 and 6 months

change from baseline, improvement

componentsAST, change, ALT, change

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from baseline high sensitivity C-reactive protein

Time frame:3 and 6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change from baseline d-dimer

Time frame:3 and 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline Interleukin 6

Time frame:3 and 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline blood pressure

Time frame:3 and 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline serum triglycerides

Time frame:3 and 6 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from baseline serum LDL

Time frame:3 and 6 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of Adverse events

Time frame:3 and 6 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of subjects with Adverse events

Time frame:3 and 6 months

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile

Time frame:6 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Neurocognitive performance- change in domain averages on a standard neuropsychological profile

Time frame:6 months

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline plasma soluble cluster of differentiation 14 (CD14)

Time frame:3 and 6 months

change from baseline, improvement

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.