AMPLITUDE-L

TerminatedPhase 3Results posted

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Lead sponsor

Sanofi

Asset

Efpeglenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

370

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT03713684

Org study IDEFC14893

Secondary IDU1111-1189-5009UTN

Timeline

Milestones

Study first posted2018-10-22actual

Study start2018-11-09actual

Primary completion2020-11-20actual

Study completion2021-01-04actual

Last update posted2021-12-02actual

Results first posted2021-12-02actual

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

•Participant must be greater than or equal to (>=)18 years of age at the time of signing the informed consent.

•Participants with T2DM.

•Diabetes diagnosed at least 1 year before screening.

•Participants on basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening.

•HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.

Exclusion criteria

•History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.

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

•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 requiring medical treatment within 6 months prior to screening.

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

•Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).

•Body weight change of >=5 kilograms within the last 3 months prior to screening.

•Systolic blood pressure greater than (>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.

•End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m^2.

•Laboratory findings at the screening Visit:

–Alanine aminotransferase or aspartate aminotransferase >3 * upper limit of normal (ULN) or total bilirubin >1.5*ULN (except in case of documented Gilbert's syndrome);

–Amylase and/or lipase: >3*ULN;

–Calcitonin >=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter [pg/mL]).

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

•Pregnant (confirmed 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 or who were unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention.

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

Endpoints (7)

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

1 endpoint

Secondary/protocol endpoint

Change From Baseline to Week 30 and Week 56 in Body Weight

Time frame:Baseline to Week 30 and Week 56

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms	95% CI
PlaceboWeek 30	0.29	—
Week 56	0.66	—
Efpeglenatide 2 mgWeek 30	-0.68	—
Week 56	-2.39	—
Efpeglenatide 4 mgWeek 30	-1.99	—
Week 56	-1.77	—
Efpeglenatide 6 mgWeek 30	-3.14	—
Week 56	-2.85	—

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change From Baseline to Week 30 in HbA1c

Time frame:Baseline to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Placebo	-0.33	—
Efpeglenatide 2 mg	-1.27	—
Efpeglenatide 4 mg	-1.24	—
Efpeglenatide 6 mg	-1.43	—

Secondary/protocol endpoint

Number of Participants With HbA1c <7.0% at Week 30

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	10	—
Efpeglenatide 2 mg	32	—
Efpeglenatide 4 mg	28	—
Efpeglenatide 6 mg	40	—

Secondary/protocol endpoint

Change From Baseline to Week 56 in HbA1c

Time frame:Baseline to Week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Placebo	-0.32	—
Efpeglenatide 2 mg	-1.08	—
Efpeglenatide 4 mg	-1.23	—
Efpeglenatide 6 mg	-1.16	—

Secondary/protocol endpoint

Change From Baseline to Week 30 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), millimoles per liter (mmol/L)	95% CI
Placebo	-0.41	—
Efpeglenatide 2 mg	-1.34	—
Efpeglenatide 4 mg	-1.33	—
Efpeglenatide 6 mg	-2.22	—

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia)

Time frame:Baseline up to Week 56

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
PlaceboDocumented symptomatic hypoglycemia (<54 mg/dL)	4	—
Severe hypoglycemia	1	—
Efpeglenatide 2 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	8	—
Severe hypoglycemia	2	—
Efpeglenatide 4 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	10	—
Severe hypoglycemia	1	—
Efpeglenatide 6 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	9	—
Severe hypoglycemia	2	—

Secondary/protocol endpoint

Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year

Time frame:Baseline up to Week 56

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), events per participant-year	95% CI
PlaceboDocumented symptomatic hypoglycemia (<54 mg/dL)	0.07	—
Severe hypoglycemia	0.09	—
Efpeglenatide 2 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	0.27	—
Severe hypoglycemia	0.05	—
Efpeglenatide 4 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	0.45	—
Severe hypoglycemia	0.05	—
Efpeglenatide 6 mgDocumented symptomatic hypoglycemia (<54 mg/dL)	0.46	—
Severe hypoglycemia	0.04	—

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 in people with suboptimally controlled type 2 diabetes: The AMPLITUDE-D, AMPLITUDE-L and AMPLITUDE-S randomized controlled trials.
Diabetes, obesity & metabolism2023 Aug (month)PMID37013892doi:10.1111/dom.15079via pubmed acronym asset candidate

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.