CompletedPhase 1

A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 23-35•HbA1c 7-10%

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04823208

Org study ID17609

Secondary IDJ1I-JE-GZBCEli Lilly and Company

Timeline

Milestones

Study first posted2021-03-30actual

Study start2021-05-24actual

Primary completion2022-06-23actual

Study completion2022-06-23actual

Last update posted2022-08-22actual

Assets

Investigational agents

Retatrutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year.

•Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at lead-in and screening

•Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m²), inclusive, and a body weight of at least 54 kilograms (Kg).

•Males and females not of childbearing potential

Exclusion criteria

•Have type 1 diabetes mellitus (T1DM)

•Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization

•Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

•Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligram per deciliter (mg/dL).

•Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).

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 in Body Weight

Time frame:Baseline through Day 78

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Mean Daily Plasma Glucose (PG)

Time frame:Baseline through Day 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Glycated Hemoglobin (HbA1c)

Time frame:Baseline through Day 78

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline through Day 78

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Day 106

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Time frame:Predose on Day 1 through Day 81

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

Time frame:Predose on Day 1 through Day 81

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 6, 2026 snapshot.