DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01406262

CompletedPhase 1

Albiglutide Thorough ECG Study in Healthy Volunteers

A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

94

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-30•Healthy volunteers

Primary endpoint

•QTc interval

Identifiers

Registered as

NCT IDNCT01406262
Org study ID107085

Timeline

Milestones

Study start2011-07-06actual
Study first posted2011-08-01estimated
Primary completion2011-12-29actual
Study completion2011-12-29actual
Last update posted2017-06-08actual

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy male or nonpregnant, nonlactating female
•Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
•BMI is ≥18 kg/m2 and ≤30 kg/m2
•Nonsmoker

Exclusion criteria

•Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
•History of arrythmia or use of antiarrhythmic agents
•History of any anaphylactic reaction to any drug
•History of significant cardiovascular or pulmonary dysfunction
•Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
•History of alcohol or substance abuse
•History of GI surgery that could influence gastric emptying
•Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
•History of pancreatitis

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

QTc interval

Time frame:6 weeks

change from baseline, descriptive

Secondary/protocol endpoint

QTc interval

Time frame:Day 4

change from baseline, descriptive

Secondary/protocol endpoint

QT interval

Time frame:Day -1 and Day 40

change from baseline, descriptive

Secondary/protocol endpoint

Number of participants with adverse events

Time frame:6 weeks

Treatment-emergent AEs (any)

event count, event

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.