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A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

Primary Purpose

Obesity

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo (Cohorts 1 and 2)
PF-06882961 (Cohorts 1 and 2)
Placebo (Cohort 3)
PF-06882961 (Cohort 3)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
  • Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
  • Any malignancy not considered cured
  • Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
  • History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
  • Symptomatic gallbladder disease
  • Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
  • History of major depressive disorder or other severe psychiatric disorders within the last 2 years
  • Any lifetime history of a suicide attempt
  • Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
  • Known history of HIV
  • Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
  • Clinically relevant ECG abnormalities
  • Positive urine drug screen
  • Participation in a formal weight reduction program within 90 days prior to visit 1

Sites / Locations

  • Pinnacle Research Group, LLC
  • Anaheim Clinical Trials, LLC
  • Velocity Clinical Research - Westlake
  • Alliance for Multispecialty Research, LLC
  • Optimus U Corporation
  • Clinical Neuroscience Solutions, Inc.
  • ForCare Clinical Research
  • Clinical Investigation Specialists
  • MediSphere Medical Research Center, LLC
  • Velocity Clinical Research, Valparaiso
  • Cotton O'Neil Clinical Research Center
  • L-MARC Research Center
  • ActivMed Practices & Research, LLC
  • Velocity Clinical Research, Omaha
  • PMG Research of Hickory, LLC
  • PMG Research of Raleigh, LLC
  • PMG Research of Salisbury, LLC
  • PMG Research of Wilmington, LLC
  • Lillestol Research LLC
  • Velocity Clinical Research, Inc.
  • Clinical Trials of South Carolina
  • Coastal Carolina Research Center
  • Palmetto Clinical Research
  • Palmetto Primary Care Physicians (Sub-I physicals only)
  • Internal Medicine and Pediatric Associates of Bristol, PC
  • PMG Research, Inc. d/b/a PMG Research of Knoxville
  • Clinical Neuroscience Solutions, Inc.
  • Rivergrove Medical Clinic
  • Aggarwal and Associates Limited
  • Milestone Research , Inc
  • Manna Research Toronto
  • Ecogene-21
  • Diex Recherche Sherbrooke Inc.
  • Centre de Recherche Saint-Louis
  • Alpha Recherche Clinique
  • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo Center Clinic
  • Fukuwa Clinic
  • Medical Corporation Heishinkai ToCROM Clinic
  • China Medical University Hospital
  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo (Cohorts 1 and 2)

PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)

PF-06882961 80 mg BID, 1-week titration (Cohort 1)

PF-06882961 120 mg BID, 1-week titration (Cohort 1)

PF-06882961 160 mg BID, 1-week titration (Cohort 1)

PF-06882961 200 mg BID, 1-week titration (Cohort 1)

PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)

PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)

PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)

Placebo (Cohort 3)

PF-06882961 80 mg BID, 4-week titration (Cohort 3)

PF-06882961 140 mg BID, 4-week titration (Cohort 3)

PF-06882961 200 mg BID, 4-week titration (Cohort 3)

Arm Description

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.

The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.

The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.

The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.

Outcomes

Primary Outcome Measures

Percent change from baseline in body weight

Secondary Outcome Measures

Body weight loss of greater than or equal to 5%
Percent change from baseline in body weight
Absolute change from baseline in waist circumference
Absolute change from baseline in waist-to-hip ratio
Absolute change from baseline in hemoglobin A1c
Absolute change from baseline in fasting plasma glucose
Incidence of treatment emergent adverse events (AEs and SAEs)
Incidence of treatment emergent clinically significant laboratory abnormalities
Incidence of treatment emergent clinically significant vital sign abnormalities
Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities
Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9)

Full Information

First Posted
January 11, 2021
Last Updated
October 5, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04707313
Brief Title
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Official Title
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
October 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood. This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening). There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Cohorts 1 and 2)
Arm Type
Placebo Comparator
Arm Title
PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)
Arm Type
Experimental
Arm Description
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.
Arm Title
PF-06882961 80 mg BID, 1-week titration (Cohort 1)
Arm Type
Experimental
Arm Description
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.
Arm Title
PF-06882961 120 mg BID, 1-week titration (Cohort 1)
Arm Type
Experimental
Arm Description
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.
Arm Title
PF-06882961 160 mg BID, 1-week titration (Cohort 1)
Arm Type
Experimental
Arm Description
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.
Arm Title
PF-06882961 200 mg BID, 1-week titration (Cohort 1)
Arm Type
Experimental
Arm Description
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.
Arm Title
PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)
Arm Type
Experimental
Arm Description
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.
Arm Title
PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)
Arm Type
Experimental
Arm Description
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.
Arm Title
PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)
Arm Type
Experimental
Arm Description
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.
Arm Title
Placebo (Cohort 3)
Arm Type
Placebo Comparator
Arm Title
PF-06882961 80 mg BID, 4-week titration (Cohort 3)
Arm Type
Experimental
Arm Description
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.
Arm Title
PF-06882961 140 mg BID, 4-week titration (Cohort 3)
Arm Type
Experimental
Arm Description
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.
Arm Title
PF-06882961 200 mg BID, 4-week titration (Cohort 3)
Arm Type
Experimental
Arm Description
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.
Intervention Type
Drug
Intervention Name(s)
Placebo (Cohorts 1 and 2)
Intervention Description
4 matching placebo tablets taken twice daily
Intervention Type
Drug
Intervention Name(s)
PF-06882961 (Cohorts 1 and 2)
Intervention Description
Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo (Cohort 3)
Intervention Description
2 matching placebo tablets taken twice daily
Intervention Type
Drug
Intervention Name(s)
PF-06882961 (Cohort 3)
Intervention Description
Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily.
Primary Outcome Measure Information:
Title
Percent change from baseline in body weight
Time Frame
Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Secondary Outcome Measure Information:
Title
Body weight loss of greater than or equal to 5%
Time Frame
Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Title
Percent change from baseline in body weight
Time Frame
Cohorts 1 and 2: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22; Cohort 3: Baseline, Week 4, 8, 12, 16, 20, 24 and 28
Title
Absolute change from baseline in waist circumference
Time Frame
Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Title
Absolute change from baseline in waist-to-hip ratio
Time Frame
Cohorts 1 and 2: Baseline and Week 26; Cohort 3: Baseline and Week 32
Title
Absolute change from baseline in hemoglobin A1c
Time Frame
Cohorts 1 and 2: Baseline, Week 16 and 26; Cohort 3: Baseline, Week 16, 24 and 32
Title
Absolute change from baseline in fasting plasma glucose
Time Frame
Cohorts 1 and 2: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26; Cohort 3: Baseline, Week 4, 8, 12, 16, 20, 24, 28 and 32
Title
Incidence of treatment emergent adverse events (AEs and SAEs)
Time Frame
Cohorts 1 and 2: Baseline up to Week 31; Cohort 3: Baseline up to Week 37
Title
Incidence of treatment emergent clinically significant laboratory abnormalities
Time Frame
Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Title
Incidence of treatment emergent clinically significant vital sign abnormalities
Time Frame
Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Title
Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities
Time Frame
Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Title
Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34
Title
Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9)
Time Frame
Cohorts 1 and 2: Baseline up to Week 28; Cohort 3: Baseline up to Week 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2 Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1 Exclusion Criteria: Any condition possibly affecting drug absorption Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1 Any malignancy not considered cured Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis Symptomatic gallbladder disease Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders History of major depressive disorder or other severe psychiatric disorders within the last 2 years Any lifetime history of a suicide attempt Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis Known history of HIV Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic) Clinically relevant ECG abnormalities Positive urine drug screen Participation in a formal weight reduction program within 90 days prior to visit 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Velocity Clinical Research - Westlake
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Clinical Investigation Specialists
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Velocity Clinical Research, Valparaiso
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
ActivMed Practices & Research, LLC
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Velocity Clinical Research, Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Palmetto Primary Care Physicians (Sub-I physicals only)
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
PMG Research, Inc. d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Rivergrove Medical Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Milestone Research , Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Manna Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3421019
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

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