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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04617275
• Collaborator: (none)
• Enrollment: 151
• Locations: 38
• Arms: 7
• Actual Duration (Months): 10.3
• Patients Per Site: 4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Obesity	Drug: PF-06882961; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 6, 2021
• Actual Primary Completion Date: Nov 17, 2021
• Actual Study Completion Date: Nov 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)
Experimental: Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)
Experimental: Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)
Experimental: Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)
Placebo Comparator: Arm 5 - Placebo in subjects with T2DM and Obesity Matching Placebo tablets taken twice a day (BID)	Other: Placebo; Placebo comparator will be provided as tablets twice daily for 12 weeks
Experimental: Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)
Experimental: Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity 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	Drug: PF-06882961; PF-68882961 will be provided as tablets twice a day (BID)

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of treatment emergent adverse events (AEs and SAEs) [Baseline through followup (Day 112)]

Secondary Outcome Measures

1. Change from baseline in fasting plasma glucose [Baseline through followup (Day 91)]

2. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline through followup (Day 91)]

3. Change from baseline in body weight [Baseline through followup (Day 91)]

4. Incidence of treatment emergent clinical laboratory abnormalities [Baseline through Visit 10 (Day 91)]

5. Incidence of treatment emergent vital signs [Baseline through Visit 10 (Day 91)]

6. Incidence of treatment emergent Electrocardiogram (ECG) abnormalities [Baseline through Visit 10 (Day 91)]

7. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [Baseline through Visit 10 (Day 91)]

8. Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9) [Baseline through Visit 10 (Day 91)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85053
2	Unity Health - Searcy Medical Center	Searcy	Arkansas	United States	72143
3	Catalina Research Institute, LLC	Montclair	California	United States	91763
4	Desert Oasis Healthcare Medical Group	Palm Springs	California	United States	92262
5	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California	United States	91730
6	California Research Foundation	San Diego	California	United States	92123-1881
7	University Clinical Investigators, Inc.	Tustin	California	United States	92780
8	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
9	Emerson Clinical Research Institute	Washington	District of Columbia	United States	20011
10	Innovative Research of West Florida, Inc.	Clearwater	Florida	United States	33756
11	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
12	Acevedo Clinical Research Associates	Miami	Florida	United States	33142
13	Pines Care Research Center, LLC	Pembroke Pines	Florida	United States	33024
14	Solaris Clinical Research	Meridian	Idaho	United States	83646
15	Meridian Clinical Research, LLC	Sioux City	Iowa	United States	51106
16	Research Integrity, LLC	Owensboro	Kentucky	United States	42303
17	Nola Care LLC	Metairie	Louisiana	United States	70006
18	Clinical Research Professionals	Chesterfield	Missouri	United States	63005
19	Meridian Clinical Research, LLC DBA Regional Clinical Research	Endwell	New York	United States	13760
20	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina	United States	27518
21	PMG Research of Charlotte, LLC	Charlotte	North Carolina	United States	28209
22	PMG Research of Hickory, LLC	Hickory	North Carolina	United States	28601
23	PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery	Rocky Mount	North Carolina	United States	27804
24	PMG Research of Rocky Mount, LLC - Patient Visits	Rocky Mount	North Carolina	United States	27804
25	Carolina Research Center, Inc.	Shelby	North Carolina	United States	28150
26	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
27	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45219
28	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania	United States	15009
29	Palmetto Clinical Research	Summerville	South Carolina	United States	29485
30	Palmetto Primary Care Physicians (physicals only)	Summerville	South Carolina	United States	29485
31	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee	United States	38119
32	Dallas Diabetes Research Center	Dallas	Texas	United States	75230
33	Juno Research, LLC	Houston	Texas	United States	77074
34	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
35	Bountiful Internal Medicine	Bountiful	Utah	United States	84010
36	Progressive Clinical Research	Bountiful	Utah	United States	84010
37	Wade Family Medicine	Bountiful	Utah	United States	84010
38	Manassas Clinical Research Center	Manassas	Virginia	United States	20110

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04617275
• Other Study ID Numbers: C3421008; GLP-1Ra Ph 2 Titration Study
• First Posted: Nov 5, 2020
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 11, 2022