DelfaGLP-1 Atlas

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CompletedPhase 1

Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects

A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function

Asset

Exenatide

GLP-1 agonist

Listed sites

4

Recruiting sites

—

Enrollment

38

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI 22-40

Primary endpoint

•24-h Area under the Curve at steady state (AUCt,ss)

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 IDNCT02320045
Org study IDITCA 650 CLP-109

Timeline

Milestones

Study first posted2014-12-19estimated
Last update posted2016-06-03estimated
Study start2014-11 (month precision)
Primary completion2015-07actual (month precision)
Study completion2015-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age25 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Body mass index between 22 and 40 kg/m²
•Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate
–Normal (≥90 mL/min/1.73 m2)
–Mild (60-89 mL/min/1.73 m2)
–Moderate (45-59 mL/min/1.73 m2)
–Moderate (>30-44 mL/min/1.73 m2)

Exclusion criteria

•History of acute metabolic complications
•Uncontrolled Hypertension
•History of Hypersensitivity to Exenatide
•Cardiovascular Disease
•History of Acute or chronic pancreatitis
•Personal or family history of Multiple endocrine neoplasia type 2
•History of Medullary thyroid cancer
•Severe renal failure, End stage renal disease or dialysis

Endpoints (7)

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

Safety / tolerability / PK
6
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Vital signs

Time frame:Approximately 67 Days

descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

24-h Area under the Curve at steady state (AUCt,ss)

Time frame:Approximately 67 Days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Rate of adverse events

Time frame:Approximately 67 Days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Severity of adverse events

Time frame:Approximately 67 Days

descriptive

Secondary/protocol endpoint

Safety laboratory parameters

Time frame:Approximately 67 Days

descriptive

Secondary/protocol endpoint

Electrocardiogram

Time frame:Approximately 67 Days

descriptive

Secondary/protocol endpoint

Physical exam

Time frame:Approximately 67 Days

descriptive

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.