Study S000448

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

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05579977
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: TERMINATED
Enrollment: 902
Start: 2022-10-27
Primary completion: 2023-07-14
Lead sponsor: Pfizer
Conditions: Diabetes Mellitus; Obesity
Interventions: DRUG:PF-07081532; OTHER:Placebo; DRUG:Rybelsus
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2022-002834-15

Registered primary outcomes

Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [Baseline (result closest prior to dosing on Day 1), Week 32]
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity) [Baseline (result closest prior to dosing on Day 1), week 32]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0004106	Evaluation of an oral small-molecule glucagon-like peptide-1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose-ranging, phase 2, randomized, placebo-controlled study. Amin NB, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 39415344 DOI	cites ClinicalTrials.gov:NCT05579977; registry reference DERIVED:39415344
R0004281	Emerging pharmacotherapies for obesity: A systematic review. Kokkorakis M, Pharmacological reviews	2025	Systematic review	PMID 39952695 DOI	cites ClinicalTrials.gov:NCT05579977; registry reference DERIVED:39952695