DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06582875

RecruitingPhase 2

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

126

estimated

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criteria

•BMI ≥27•eGFR ≥30

Primary endpoint

•Height-Adjusted Total kidney volume

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 IDNCT06582875
Org study ID24-0594
Secondary IDR01DK138915-01A1

Timeline

Milestones

Study first posted2024-09-03actual
Study start2025-03-06actual
Last update posted2025-05-06actual
Primary completion2029-06-30estimated
Study completion2029-06-30estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•18-65 years of age
•ADPKD diagnosis based on the modified Pei-Ravine criteria
•Body-mass index of ≥27 kg/m^2
•Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2
•Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months
•Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
•Ability to provide informed consent

Exclusion criteria

•Diabetes mellitus
•Tolvaptan usage or plans to initiate tolvaptan
•History of hospitalization or major surgery within the last 3 months
•Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
•Pregnancy, lactation, or unwillingness to use adequate birth control
•Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism
•History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
•Weight change of >5% in the past 3 months for any reason except post-partum weight loss
•Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings
•Presence or personal history of malignant neoplasm within 5 years prior to the day of screening
•Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2
•Prior history of pancreatitis
•Weight ≥450 lb

Endpoints (25)

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

Other (unclassified)
9
Renal / kidney
4
Cardiometabolic biomarkers
4
Weight & body composition
3
Glycemic / diabetes
2
Safety / tolerability / PK
2
Other clinical outcomes
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline, 12-months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal adiposity

Time frame:Baseline, 12-months

change from baseline, improvement

Other/protocol endpoint

Change in percent body fat

Time frame:Baseline, 12 months

Total fat mass

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HOMA-IR

Time frame:Baseline, 6-months, 12-months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-β

Time frame:Baseline, 6-months, 12-months

change from baseline, improvement

Renal / kidney

4 endpoints
Primary/protocol endpoint/low confidence

Change in height-Adjusted Total kidney volume

Time frame:Baseline, 12-months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in renal oxygen consumption

Time frame:Baseline, 12-months

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in renal blood flow

Time frame:Baseline, 12-months

change from baseline, improvement

Other/protocol endpoint

Kidney Function Decline

Time frame:Baseline, 1 month, 3 months, 6-months, 12-months

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in adiponectin (circulating)

Time frame:Baseline, 6-months, 12-months

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in leptin (circulating)

Time frame:Baseline, 6-months, 12-months

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in interleukin-6 (circulating)

Time frame:Baseline, 6-months, 12-months

change from baseline, improvement

Secondary/protocol endpoint

Change in high-sensitivity C-reactive protein (circulating)

Time frame:Baseline, 6-months, 12-months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Safety (adverse events)

Time frame:12 months

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Tolerability (dropout due to adverse events)

Time frame:12 months

Discontinuation due to AE

event count, event

Other clinical outcomes

1 endpoint
Other/protocol endpoint/low confidence

Change in free-living physical activity

Time frame:Baseline, 12-months

change from baseline, descriptive

Other (unclassified)

9 endpoints
Secondary/protocol endpoint/low confidence

Change in tumor necrosis-factor-alpha (circulating)

Time frame:Baseline, 6-months, 12-months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in 8-isoprostane (circulating)

Time frame:Baseline, 6-months, 12-months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in copeptin (circulating)

Time frame:Baseline, 6-months, 12-months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in 8-isoprostane (urinary)

Time frame:Baseline, 6-months, 12-months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in copeptin (urinary)

Time frame:Baseline, 6-months, 12-months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in gut microbiota

Time frame:Baseline, 12-months

change from baseline, descriptive

Other/protocol endpoint/low confidence

Adherence

Time frame:12 months

descriptive

Other/protocol endpoint/low confidence

Change in dietary energy Intake

Time frame:Baseline, 1 month, 6-months, 12-months

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in resting energy experniture

Time frame:Baseline, 12 months

change from baseline, descriptive

Publications (1)

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

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.