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Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

NCT05579977 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 902

Last updated 2024-08-01

Study results available
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Summary

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.

Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Conditions

Interventions

DRUG

PF-07081532

Oral glucagon-like peptide-1 receptor agonist

OTHER

Placebo

No drug

DRUG

Rybelsus

Oral Semaglutide

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-07-14
Completion
2023-09-22
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • Japan
  • Poland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579977 on ClinicalTrials.gov