CompletedPhase 1

Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Subcutaneous Doses Of PF-04603629 In Type 2 Diabetic Adult Subjects

Lead sponsor

Pfizer

Asset

PF-04603629

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoints

•Pharmacokinetics of PF-04603629 in serum after administration•Pharmacodynamic effect of single, escalating•Safety and tolerability of escalating

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00638313

Org study IDB0571001

Timeline

Milestones

Study first posted2008-03-19estimated

Last update posted2009-07-31estimated

Study start2007-08 (month precision)

Study completion2008-02actual (month precision)

Assets

Investigational agents

PF-04603629

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus

•Hb A1c lower or equal to 11%

Exclusion criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

•Evidence of diabetic complications with significant end-organ damage

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.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.

Time frame:1 week per dose group

concentration, descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.

Time frame:1 week per dose group

ratio, event

Primary/protocol endpoint

To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.

Time frame:1 week per dose group

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

No secondary outcomes listed in the protocol.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.