DelfaGLP-1 Atlas

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AMPLITUDE-O

TerminatedPhase 3Results posted

Effect of Efpeglenatide on Cardiovascular Outcomes

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

Lead sponsor

Sanofi

Asset

Efpeglenatide

Subcutaneous · GLP-1 agonist

Listed sites

353

Recruiting sites

—

Enrollment

4,076

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03496298
Org study IDEFC14828
Secondary ID2017-002954-35
Secondary IDU1111-1186-2533UTN

Timeline

Milestones

Study first posted2018-04-12actual
Study start2018-04-27actual
Primary completion2020-12-10actual
Study completion2020-12-10actual
Last update posted2021-10-15actual
Results first posted2021-10-15actual

Assets

Investigational agents

Efpeglenatide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage.
•Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.
•Female participants agreed to follow contraceptive guidance.
•Signed written informed consent.

Exclusion criteria

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
•History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
•Personal or family history of medullary thyroid cancer.
•Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
•Hospitalization for hypertensive emergency within 3 months prior to randomization.
•Planned coronary procedure or surgery after randomization.
•No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
•Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
•Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
•Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.
•Antihyperglycemic treatment had not been stable within 3 months prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
3
Renal / kidney
1

Cardiovascular outcomes

3 endpoints
Primary/protocol endpoint

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

Time frame:From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

GroupValue (number), events per 100 participant-years95% CI
Efpeglenatide 4 mg+6 mg3.93.4 – 4.5
Placebo5.34.4 – 6.3
Hazard Ratio (HR)0.73295% CI0.583 – 0.918p<.0001Log Rank
Secondary/protocol endpoint

Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis

Time frame:From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

GroupValue (number), events per 100 participant-years95% CI
Efpeglenatide 4 mg+6 mg3.93.4 – 4.5
Placebo5.34.4 – 6.3
Hazard Ratio (HR)0.73295% CI0.583 – 0.918p0.0069Log Rank
Secondary/protocol endpoint

Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event

Time frame:From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

5-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Unstable angina hospitalization

Posted result

GroupValue (number), events per 100 participant-years95% CI
Efpeglenatide 4 mg+6 mg5.4—
Placebo6.8—
Hazard Ratio (HR)0.7995% CI0.65 – 0.96p0.02Log Rank

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint

Time frame:From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Custom renal composite

time to event, event

componentsuACR, change, eGFR, change, Kidney-replacement therapy, End-stage renal disease

Posted result

GroupValue (number), events per 100 participant-years95% CI
Efpeglenatide 4 mg+6 mg7.76.9 – 8.6
Placebo11.610.2 – 13.1
Hazard Ratio (HR)0.67595% CI0.574 – 0.794p<.0001Log Rank

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.