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PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2) for 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 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
Awards & highlights
Summary
This trial will study whether PF-06882961 is safe and effective in adults with obesity. The study will last for 26 weeks and participants will be monitored for any adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Absolute change from baseline in fasting plasma glucose
Absolute change from baseline in hemoglobin A1c
Absolute change from baseline in waist circumference
+9 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
4,595 Previous Clinical Trials
12,868,140 Total Patients Enrolled
40 Trials studying Obesity
116,342 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,044,749 Total Patients Enrolled
29 Trials studying Obesity
119,596 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
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