DelfaGLP-1 Atlas

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CompletedPhase 1

A Drug Interaction Study of Simvastatin and Albiglutide

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

40

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI ≤30

Primary endpoint

•Effect of albiglutide on the pharmacokinetics of simvastatin

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 IDNCT01147692
Org study ID108366

Timeline

Milestones

Study start2010-05-19actual
Study first posted2010-06-22estimated
Primary completion2010-08-27actual
Study completion2010-08-27actual
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 age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•no clinically significant diseases or clinically significant abnormal laboratory values
•females must be of non-childbearing potential
•body mass index (BMI) is >/=18 kg and ≤30 kg/m2
•nonsmoker
•negative drug screen

Exclusion criteria

•positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
•any clinically relevant abnormality
•female subject is pregnant or breast-feeding
•history of any anaphylactic reaction to any drug
•history of significant cardiovascular or pulmonary dysfunction
•current or chronic history of liver disease
•history of alcohol or substance abuse
•history of thyroid dysfunction or disease
•history of gastrointestinal surgery or disease
•history of pancreatitis
•previously received any GLP-1 mimetic compound (e.g., exenatide)

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

The effect of albiglutide on the pharmacokinetics of simvastatin

Time frame:42 days

descriptive

Secondary/protocol endpoint

The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

Time frame:42 days

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.