Trials / Terminated
TerminatedNCT05579977
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
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 902 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07081532 | Oral glucagon-like peptide-1 receptor agonist |
| OTHER | Placebo | No drug |
| DRUG | Rybelsus | Oral Semaglutide |
Timeline
- Start date
- 2022-10-27
- Primary completion
- 2023-07-14
- Completion
- 2023-09-22
- First posted
- 2022-10-14
- Last updated
- 2024-08-01
- Results posted
- 2024-08-01
Locations
90 sites across 8 countries: United States, Bulgaria, Canada, Czechia, Hungary, Japan, Poland, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05579977. Inclusion in this directory is not an endorsement.