Clinical trial NCT04707313: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Weight loss
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 628
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: 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).


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

Primary outcomes:
measure: Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
timeFrame: Baseline, Week 26
measure: Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
timeFrame: Baseline, Week 32
Secondary outcomes:
measure: Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)
measure: Cohort 3: Number of Participants With TEAEs and TESAEs
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)
measure: Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
measure: Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
measure: Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
measure: Cohort 3: Number of Participants According to Categorization of Vital Signs Data
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
measure: Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
measure: Cohort 3: Number of Participants According to Categorization of ECG Parameters
timeFrame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
measure: Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation
timeFrame: Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
measure: Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation
timeFrame: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
measure: Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation
timeFrame: Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
measure: Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation
timeFrame: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
measure: Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment
timeFrame: Week 26
measure: Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment
timeFrame: Week 32
measure: Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
measure: Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28
measure: Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26
timeFrame: Baseline, Week 26
measure: Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32
timeFrame: Baseline, Week 32
measure: Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26
timeFrame: Baseline, Week 26
measure: Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32
timeFrame: Baseline, Week 32
measure: Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26
timeFrame: Baseline, Weeks 16 and 26
measure: Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
timeFrame: Baseline, Weeks 16, 24 and 32
measure: Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
measure: Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Westlake
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Gurnee
country: United States
facility: Clinical Investigation Specialists
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research, Valparaiso
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Methuen
country: United States
facility: ActivMed Practices & Research, LLC
state: Massachusetts
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Moncks Corner
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Primary Care Physicians (Sub-I physicals only)
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research, Inc. d/b/a PMG Research of Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Winnipeg
country: Canada
facility: Rivergrove Medical Clinic
state: Manitoba
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: London
country: Canada
facility: Milestone Research , Inc
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: