Study S000755

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

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

Registration

Registration: NCT03496298
Acronym: AMPLITUDE-O
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: TERMINATED
Enrollment: 4076
Start: 2018-04-27
Primary completion: 2020-12-10
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Efpeglenatide (SAR439977); DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2017-002954-35; OTHER:U1111-1186-2533; NIH:2017

Registered primary outcomes

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis [From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)]

Linked records (5)

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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT03496298; registry reference DERIVED:39963952
R0006193	Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Gerstein HC, Circulation	2023	Randomized trial	PMID 36802715 DOI	cites ClinicalTrials.gov:NCT03496298; registry reference DERIVED:36802715
R0004602	Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Lam CSP, Circulation	2022	Randomized trial	PMID 34775781 DOI	cites ClinicalTrials.gov:NCT03496298; registry reference DERIVED:34775781
R0008142	Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Gerstein HC, Diabetes, obesity & metabolism	2021	Protocol	PMID 33026143 DOI	cites ClinicalTrials.gov:NCT03496298; registry reference DERIVED:33026143
R0014754	Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. Gerstein HC, The New England journal of medicine	2021	Randomized trial	PMID 34215025 DOI	cites ClinicalTrials.gov:NCT03496298; registry reference RESULT:34215025