NCT04707313|CompletedPhase 2ResultsDMCFDA Drug

A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

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

Pfizer ClinicalTrials.gov

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2 other identifiers

C34210192020-001312-19

Study Type

interventional

Target

628

Locations

4 countries

Sites

Timeline

RegisteredJan 2021

StartedJan 2021

CompletionOct 2023

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

628

participants targeted

Target at P75+ for phase_2 obesity

Timeline

Completed

Started Jan 2021

Typical duration for phase_2 obesity

Geographic Reach

4 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

January 11, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed

16 days until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed

12 months until next milestone

Results Posted

Study results publicly available

October 9, 2024

Completed

Last Updated

November 5, 2024

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

January 11, 2021

Results QC Date

September 12, 2024

Last Update Submit

October 11, 2024

Conditions

Obesity

Keywords

Weight loss

Outcome Measures

Primary Outcomes (2)

Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \[\*\](back-transformed LS Mean minus \[-\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Baseline, Week 26
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Baseline, Week 32

Secondary Outcomes (24)

Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
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)
Cohort 3: Number of Participants With TEAEs and TESAEs
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)
Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
+19 more secondary outcomes

Study Arms (13)

Placebo (Cohorts 1 and 2)

PLACEBO COMPARATOR

Drug: Placebo (Cohorts 1 and 2)