Study S001063

A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04617275
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 151
Start: 2021-01-06
Primary completion: 2021-11-17
Lead sponsor: Pfizer
Conditions: Diabetes; Obesity
Interventions: DRUG:PF-06882961; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:GLP-1Ra Ph 2 Titration Study

Registered primary outcomes

Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity [Baseline through follow-up (Day 112)]

Linked records (1)

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
R0007238	Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes. Saxena AR, Diabetes, obesity & metabolism	2023	Randomized trial	PMID 37311722 DOI	cites ClinicalTrials.gov:NCT04617275; registry reference DERIVED:37311722