GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 19-35

Primary endpoints

•Plasma concentration (steady state)•Core Study

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 IDNCT02650479

Org study IDITCA-650-CLP-114

Timeline

Milestones

Study first posted2016-01-08estimated

Last update posted2017-01-27estimated

Study start2016-01 (month precision)

Primary completion2016-04actual (month precision)

Study completion2016-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body mass index (BMI) between 19 to 35 kg/m2 inclusive.

•Women of child bearing potential - use of an additional adequate method of contraception during the study and until 1 additional menstrual cycle following the end-of-study (EOS) visit. Adequate methods of contraception for women of child bearing potential (WOCBP) include: mechanical products (ie, intrauterine device [IUD]-copper IUD); or barrier methods (eg, diaphragm, condoms, cervical cap) with spermacide.

•Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), and bilirubin within normal range at Screening.

•Fasting triglycerides within the normal range at Screening

Exclusion criteria

•History of type 1 or type 2 diabetes, or history of hypoglycemia.

•History or evidence of myocardial infarction, congestive heart failure, syncope not related to heart arrhythmia, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke or TIA.

•History of atrial fibrillation, flutter, or non-sustained or sustained VT.

•Personal or family history of sudden death or long QT syndrome.

•History of uncontrolled hypertension.

•History or evidence of acute or chronic pancreatitis.

•History of liver disease.

•Abnormal renal function.

•History of medullary thyroid cancer or a personal or family history of multiple endocrine neoplasia type 2.

•Thyroid-stimulating hormone (TSH) outside of normal limits at Screening .

•Weight loss surgery.

•History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). (Subjects who have been disease free for greater than 5 years may be included.)

•History of active alcohol within 1 year prior to Screening.

•History of drug abuse within 5 years prior to Screening or a positive prestudy drug screen.

•Weekly consumption of more than 14 alcoholic beverages for females and more than 21 alcoholic beverages for males.

•Smoke more than 10 cigarettes per day.

•Excessive in xanthine consumption (more than 5 cups of coffee or equivalent per day).

•History of hypersensitivity to any of the medications used in this study.

•Women that are pregnant, lactating, or planning to become pregnant.

•History of or positive results on screening tests for hepatitis B and/or hepatitis C and/or human immunodeficiency virus (HIV).

•History or evidence of immunocompromised status.

•Prior or current treatment with any GLP-1 receptor agonist (eg, Bydureon™, Byetta®, Victoza®, Tanzeum® or exogenous native GLP-1) or prior participation in an ITCA 650 clinical trial.

•Any gastrointestinal complaints within 7 days prior to first dosing.

•Use of medications within 14 days of first dose other than hormone replacement therapy and oral contraceptives.

•Chronic (8 consecutive days or greater) treatment with systemic corticosteroids.

Endpoints (17)

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.

Safety / tolerability / PK

17 endpoints

Primary/protocol endpoint

Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL

Time frame:35 days

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Core Study: Changes to QTc interval changes (threshold > 10 msec) measurements

Time frame:56 days

threshold achievement, event

Secondary/protocol endpoint

Pilot Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs

Time frame:35 days

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Core Study: Measurement of exenatide plasma concentrations and relationship to changes in QTc interval measurements

Time frame:56 days

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Core Study: Changes in PR, RR, QRS, QT, T- and U- wave morphology

Time frame:56 days

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Core Study: Measurement of QTc interval changes moxifloxacin as active control

Time frame:56 days

change from baseline, descriptive

Secondary/protocol endpoint

Core Study: Adverse events as assessed by subjective subject reporting, laboratory testing, ECG, physical examinations, and vital signs

Time frame:56 days

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Pilot Study: Maximum concentration (CMax) of exenatide

Time frame:35 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pilot Study: Time to maximum concentration (TMax) of exenatide

Time frame:35 days

Tmax

descriptive

Secondary/protocol endpoint

Pilot Study: Area under the curve (AUC) of exenatide

Time frame:35 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pilot Study: Steady state concentration (Css) of exenatide

Time frame:35 days

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Pilot Study: Half life (T1/2) of exenatide

Time frame:35 days

Half-life

descriptive

Secondary/protocol endpoint

Core Study: Half life (T1/2) of exenatide

Time frame:56 days

Half-life

descriptive

Secondary/protocol endpoint

Core Study: Steady state concentration (Css) of exenatide

Time frame:56 days

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Core Study: Area under the curve (AUC) of exenatide

Time frame:56 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Core Study: Maximum concentration (CMax)

Time frame:56 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

Core Study: Time to maximum concentration (TMax) of exenatide

Time frame:56 days

Tmax

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.