AMPLITUDE-M

CompletedPhase 3Results posted

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Lead sponsor

Hanmi Pharmaceutical Company Limited

Asset

Efpeglenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

406

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT03353350

Org study IDEFC14822

Secondary ID2016-001857-42

Secondary IDU1111-1182-1806UTN

Timeline

Milestones

Study first posted2017-11-27actual

Study start2017-12-05actual

Primary completion2020-01-29actual

Study completion2020-09-07actual

Last update posted2022-01-18actual

Results first posted2022-01-18actual

Assets

Investigational agents

Efpeglenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants must be at least 18 years of age at the time of signing the informed consent.

•Participants with T2DM, and treated with diet and exercise.

•Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.

Exclusion criteria

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.

•History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.

•Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).

•Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.

•Body weight change of ≥5 kg within the last 3 months prior to Screening.

•Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization.

•End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.

•Laboratory findings at the Screening Visit:

•Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).

•Amylase and/or lipase: >3 times the ULN laboratory range.

•Calcitonin ≥5.9 pmol/L (20 pg/mL).

•Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.

•History of drug or alcohol abuse within 6 months prior to the time of Screening.

•Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.

•Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.

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

Endpoints (9)

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight at Week 30

Time frame:Baseline to Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Placebo	-1.35	—
Efpeglenatide 2 mg	-1.01	—
Efpeglenatide 4 mg	-3.34	—
Efpeglenatide 6 mg	-3.19	—

Secondary/protocol endpoint

Change in Body Weight at Week 56

Time frame:Baseline to Week 56

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Placebo	-1.26	—
Efpeglenatide 2 mg	-0.94	—
Efpeglenatide 4 mg	-3.24	—
Efpeglenatide 6 mg	-1.82	—

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c) (%)

Time frame:Baseline to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), HbA1c (%)	95% CI
Placebo	-0.46	—
Efpeglenatide 2 mg	-1.14	—
Efpeglenatide 4 mg	-1.48	—
Efpeglenatide 6 mg	-1.59	—

Secondary/protocol endpoint

Change in HbA1c (%)

Time frame:Baseline to Week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), HbA1c (%)	95% CI
Placebo	-0.52	—
Efpeglenatide 2 mg	-1.18	—
Efpeglenatide 4 mg	-1.51	—
Efpeglenatide 6 mg	-1.51	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Baseline to Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), FPG (mmol/L)	95% CI
Placebo	8.59	—
Efpeglenatide 2 mg	-0.87	—
Efpeglenatide 4 mg	6.84	—
Efpeglenatide 6 mg	6.55	—

Secondary/protocol endpoint

HbA1c <7%

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	26	—
Efpeglenatide 2 mg	60	—
Efpeglenatide 4 mg	66	—
Efpeglenatide 6 mg	76	—

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Hypoglycemic Participants

Time frame:Baseline to Week 56

Documented hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	2	—
Efpeglenatide 2 mg	10	—
Efpeglenatide 4 mg	14	—
Efpeglenatide 6 mg	14	—

Secondary/protocol endpoint

Hypoglycemic Events

Time frame:Baseline to Week 56

event count, event

Posted result

Group	Value (number), Number of events	95% CI
Placebo	2	—
Efpeglenatide 2 mg	10	—
Efpeglenatide 4 mg	14	—
Efpeglenatide 6 mg	14	—

Secondary/protocol endpoint

Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline to Week 56

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Number of Treatment Emergent AEs	95% CI
Placebo	79	—
Efpeglenatide 2 mg	80	—
Efpeglenatide 4 mg	79	—
Efpeglenatide 6 mg	83	—

Publications (1)

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

Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.
Diabetes care2022 Jul 7PMID35671039doi:10.2337/dc21-2656via clinicaltrials gov reference derived + pubmed nct search

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.