A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes; Obesity

Treatments: Drug: PF-06882961; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617275

C3421008

GLP-1Ra Ph 2 Titration Study (Other Identifier)

Details and patient eligibility

About

This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity

Enrollment: 151 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

Exclusion criteria

• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1).
• Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis.
• History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years.
• Any lifetime history of a suicide attempt.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 7 patient groups, including a placebo group

Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID

Treatment:

Drug: PF-06882961

Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID

Treatment:

Drug: PF-06882961

Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID

Treatment:

Drug: PF-06882961

Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID

Treatment:

Drug: PF-06882961

Arm 5 - Placebo in subjects with T2DM and Obesity

Placebo Comparator group

Description:

Matching Placebo tablets taken twice a day (BID)

Treatment:

Other: Placebo

Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID

Treatment:

Drug: PF-06882961

Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity

Experimental group

Description:

The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID

Treatment:

Drug: PF-06882961