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A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, follow-up (week 31)
Summary
This trial is testing a new weight loss pill called PF-06882961. It targets people with obesity who do not have diabetes and haven't been in a weight loss program recently. The pill is taken regularly, and researchers will monitor changes in weight and how well participants tolerate the medicine.
Eligible Conditions
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, follow-up (week 31)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, follow-up (week 31)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
Secondary study objectives
Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
+21 moreTrial Design
13Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06882961 80 mg BID, 4-week titration (Cohort 3)Experimental Treatment1 Intervention
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID.
Group II: PF-06882961 80 mg BID, 1-week titration (Cohort 1)Experimental Treatment1 Intervention
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.
Group III: PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)Experimental Treatment1 Intervention
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.
Group IV: PF-06882961 200 mg BID, 4-week titration (Cohort 3)Experimental Treatment1 Intervention
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.
Group V: PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)Experimental Treatment1 Intervention
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID.
Group VI: PF-06882961 200 mg BID, 1-week titration (Cohort 1)Experimental Treatment1 Intervention
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.
Group VII: PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)Experimental Treatment1 Intervention
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID.
Group VIII: PF-06882961 160 mg BID, 1-week titration (Cohort 1)Experimental Treatment1 Intervention
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.
Group IX: PF-06882961 140 mg BID, 4-week titration (Cohort 3)Experimental Treatment1 Intervention
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID.
Group X: PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)Experimental Treatment1 Intervention
The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID.
Group XI: PF-06882961 120 mg BID, 1-week titration (Cohort 1)Experimental Treatment1 Intervention
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.
Group XII: Placebo (Cohorts 1 and 2)Placebo Group1 Intervention
Group XIII: Placebo (Cohort 3)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06882961 (Cohort 3)
2021
Completed Phase 2
~630
PF-06882961 (Cohorts 1 and 2)
2021
Completed Phase 2
~630
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,214 Total Patients Enrolled
43 Trials studying Obesity
116,697 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,255 Total Patients Enrolled
32 Trials studying Obesity
119,951 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that might disrupt the way your body absorbs the study drug.You have any type of cancer that is not considered cured.You have gallbladder disease and are experiencing symptoms.You have attempted suicide at any point in your life.You have had severe mental health disorders, such as major depression, in the past two years.You have had acute pancreatitis within the last 6 months or you have a history of chronic pancreatitis.You have a medical history or characteristics that suggest your obesity is caused by genetics, a medical condition, or other hormonal imbalances.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2)
- Group 2: PF-06882961 200 mg BID, 4-week titration (Cohort 3)
- Group 3: PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2)
- Group 4: PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2)
- Group 5: PF-06882961 80 mg BID, 4-week titration (Cohort 3)
- Group 6: PF-06882961 140 mg BID, 4-week titration (Cohort 3)
- Group 7: PF-06882961 160 mg BID, 1-week titration (Cohort 1)
- Group 8: PF-06882961 200 mg BID, 1-week titration (Cohort 1)
- Group 9: Placebo (Cohorts 1 and 2)
- Group 10: PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)
- Group 11: PF-06882961 80 mg BID, 1-week titration (Cohort 1)
- Group 12: PF-06882961 120 mg BID, 1-week titration (Cohort 1)
- Group 13: Placebo (Cohort 3)
Awards:
This trial has 0 awards, including:Obesity Patient Testimony for trial: Trial Name: NCT04707313 — Phase 2