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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 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 weeks
Treatment ~ Varies
Follow Up ~week 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, follow-up (week 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, follow-up (week 31) for reporting.

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 more

Trial 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
4,658 Previous Clinical Trials
17,876,797 Total Patients Enrolled
42 Trials studying Obesity
116,405 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,917,973 Total Patients Enrolled
31 Trials studying Obesity
119,659 Patients Enrolled for Obesity

Media Library

PF-06882961 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04707313 — Phase 2
PF-06882961 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04707313 — Phase 2
Obesity Research Study Groups: PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 200 mg BID, 4-week titration (Cohort 3), PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 80 mg BID, 4-week titration (Cohort 3), PF-06882961 140 mg BID, 4-week titration (Cohort 3), PF-06882961 160 mg BID, 1-week titration (Cohort 1), PF-06882961 200 mg BID, 1-week titration (Cohort 1), 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), Placebo (Cohort 3)
Obesity Clinical Trial 2023: PF-06882961 Highlights & Side Effects. Trial Name: NCT04707313 — Phase 2
Obesity Patient Testimony for trial: Trial Name: NCT04707313 — Phase 2
~132 spots leftby Nov 2025
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