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

Study 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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 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
4,567 Previous Clinical Trials
10,911,243 Total Patients Enrolled
40 Trials studying Obesity
116,332 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,411 Total Patients Enrolled
29 Trials studying Obesity
119,596 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 80 mg BID, 4-week titration (Cohort 3), 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, 4-week titration (Cohort 3), PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2), 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment figure for this clinical experiment?

"Sadly, this particular trial has ceased recruitment. Initially posted on January 29th 2021 and last edited October 28th 2022, it is no longer welcoming new candidates. However, there are presently 957 clinical trials concerning obesity that have open enrollment and 1 study recruiting patients for PF-06882961."

Answered by AI

For whom is this experimental program available?

"This trial is currently recruiting 497 people with obesity, aged between 18 and 75. The enrolment requirements are that they must have a Body Mass Index (BMI) of 30.0 kg/m2 or higher, plus their weight has to remain consistent for the three months prior to visit 1 i.e., no more than 5kg fluctuation in bodyweight."

Answered by AI

Has the Food and Drug Administration given their stamp of approval to PF-06882961?

"Our team has conferred a safety rating of 2 to PF-06882961, signifying that although there is evidence for its security profile, the efficacy data remains inconclusive."

Answered by AI

Are seniors above the age of sixty eligible to join this clinical experiment?

"This research requires that all participants are at least 18 years of age and no more than 75."

Answered by AI

Is the enrollment process for this experiment still open?

"The information available on clinicaltrials.gov conveys that this research endeavour is not presently looking for participants, having been first posted on January 29th 2021 and most recently updated October 28th 2022. Nevertheless, 958 other studies are actively searching for patients at the moment."

Answered by AI

Has this been done before? Is this an unprecedented clinical trial?

"Pfizer-funded research into PF-06882961 began in 2021, when they launched a Phase 1 study with 497 participants. Following the successful completion of this trial, it proceeded to its second phase and has since been tested in one live study sponsored again by Pfizer."

Answered by AI

Are there multiple locations where this trial is being conducted in the city?

"43 trial sites are currently accepting applications, including Velocity Clinical Research - Westlake in Los Angeles, Meridian Clinical Research LLC in Omaha and Alliance for Multispecialty Research - Medisphere Medical Research Center in Evansville. Furthermore, many other locations across the nation may also be participating."

Answered by AI

What other research efforts have there been involving PF-06882961?

"PF-06882961 was initially studied by PMG Research of Bristol, LLC in 2021. Since then, 18334 trials have been completed and 1 trial is still active with a significant number taking place in Los Angeles."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Tennessee
North Carolina
Other
How old are they?
65+
18 - 65
What site did they apply to?
PMG Research of Salisbury, LLC
Clinical Investigation Specialists
PMG Research, Inc. d/b/a PMG Research of Knoxville
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I'm only 24, and d. Need to lose weight. I need help with my weight…. i need to make some decent money.
PatientReceived 2+ prior treatments
Looking to find results in weight loss.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When does it begin? Will you call for screening? What exactly does it entail?
PatientReceived no prior treatments
Is there a site in Wilmington NC, morehead city nc or new Bern nc?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Clinical Investigation Specialists: < 24 hours
  2. Alliance for Multispecialty Research, LLC: < 24 hours
  3. Clinical Neuroscience Solutions, Inc.: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
2021. "A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04707313.
~151 spots leftby Apr 2025
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