GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus

A Phase 1, Randomized, Placebo-Controlled, Sequential Parallel Group, Multiple Dose Escalation Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of 4, Once-Weekly Subcutaneous Doses Of PF-04603629 To Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Pfizer

Asset

PF-04603629

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 22-40•HbA1c 7-11%

Primary endpoints

•Pharmacokinetics of PF-04603629 in serum after administration of escalating•Effects of multiple, escalating, subcutaneously injected doses of PF-04603629•To describe the safety and tolerability of escalating, multiple

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 IDNCT00637338

Org study IDB0571002

Timeline

Milestones

Study first posted2008-03-17estimated

Last update posted2009-07-31estimated

Study start2008-04 (month precision)

Primary completion2008-09actual (month precision)

Study completion2008-09actual (month precision)

Assets

Investigational agents

PF-04603629

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). Subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.

•Male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.

•Body Mass Index (BMI) of approximately 22 to 40 kg/m2

•Fasting C-peptide test result must be >0.4 nmol/L.

•HbA1c ≥7% and ≤11%. If the subject requires to be washed off a sulfonylurea, the HbA1c limits will be ≥7% and ≤9.5%.

Exclusion criteria

•Screening fasting blood glucose, ≤60 or ≥270 mg/dL. One repeat screening fasting blood glucose will be allowed.

•Previous treatment with an approved or investigational GLP-1 mimetic.

•Have a known allergy to yeast, yeast-derived or yeast containing products.

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 evaluate the effects of multiple, escalating, subcutaneously injected doses of PF-04603629, on the pharmacodynamic responses of glucose, insulin, C-peptide and glucagon during a mixed meal tolerance test (MMTT).

Time frame:4 weeks per dose group

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To characterize the pharmacokinetics of PF-04603629 in serum after administration of escalating, multiple, subcutaneously injected doses of PF-04603629 to subjects with T2DM.

Time frame:4 weeks per dose group

ratio, event

Primary/protocol endpoint

To describe the safety and tolerability of escalating, multiple, subcutaneously injected doses of PF-04603629 administered to subjects with T2DM.

Time frame:4 weeks per dose group

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

To evaluate the effect of multiple, escalating, subcutaneously injected doses of PF-04603926 on additional exploratory efficacy biomarkers related to this drug's target in subjects with T2DM.

Time frame:4 weeks per dose group

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.