Clinical trial NCT04617275: 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
Official title: A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
timeFrame: Baseline through follow-up (Day 112)
Secondary outcomes:
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Baseline through Visit 10 (Day 91)
measure: Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
timeFrame: Baseline through Visit 10 (Day 91)
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
timeFrame: Baseline through Visit 10 (Day 91)
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 13-14
measure: Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 13-14.
measure: Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2
timeFrame: Baseline, Week 2
measure: CFB in Fasting Plasma Glucose at Week 4
timeFrame: Baseline, Week 4
measure: CFB in Fasting Plasma Glucose at Week 6
timeFrame: Baseline, Week 6
measure: CFB in Fasting Plasma Glucose at Week 8
timeFrame: Baseline, Week 8
measure: CFB in Fasting Plasma Glucose at Week 10
timeFrame: Baseline, Week 10
measure: CFB in Fasting Plasma Glucose at Week 12
timeFrame: Baseline, Week 12
measure: CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2
timeFrame: Baseline, Week 2
measure: CFB in Glycolated HbA1c at Week 4
timeFrame: Baseline, Week 4
measure: CFB in Glycolated HbA1c at Week 6
timeFrame: Baseline, Week 6
measure: CFB in Glycolated HbA1c at Week 8
timeFrame: Baseline, Week 8
measure: CFB in Glycolated HbA1c at Week 10
timeFrame: Baseline, Week 10
measure: CFB in Glycolated HbA1c at Week 12
timeFrame: Baseline, Week 12
measure: CFB in Body Weight at Week 2 (Participants With T2DM)
timeFrame: Baseline, Week 2
measure: CFB in Body Weight at Week 4 (Participants With T2DM)
timeFrame: Baseline, Week 4
measure: CFB in Body Weight at Week 6 (Participants With T2DM)
timeFrame: Baseline, Week 6
measure: CFB in Body Weight at Week 8 (Participants With T2DM)
timeFrame: Baseline, Week 8
measure: CFB in Body Weight at Week 10 (Participants With T2DM)
timeFrame: Baseline, Week 10
measure: CFB in Body Weight at Week 12 (Participants With T2DM)
timeFrame: Baseline, Week 12
measure: CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 2
measure: CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 4
measure: CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 6
measure: CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 8
measure: CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 10
measure: CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Searcy
country: United States
facility: Unity Health - Searcy Medical Center
state: Arkansas
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center, LLC
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Sioux City
country: United States
facility: Meridian Clinical Research, LLC
state: Iowa
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Metairie
country: United States
facility: Nola Care LLC
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC DBA Regional Clinical Research
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC - Patient Visits
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Primary Care Physicians (physicals only)
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Bountiful
country: United States
facility: Bountiful Internal Medicine
state: Utah
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Bountiful
country: United States
facility: Wade Family Medicine
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: