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CompletedPhase 1

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

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

Assets

Dulaglutide / Retatrutide

Listed sites

4

Recruiting sites

Enrollment

72

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 23-50HbA1c 7-10.5%

Primary endpoint

Serious AEs (any)

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 IDNCT04143802
Org study ID17137
Secondary IDJ1I-MC-GZBBEli Lilly and Company

Timeline

Milestones

Study first posted2019-10-29actual
Study start2019-12-18actual
Primary completion2020-12-28actual
Study completion2020-12-28actual
Last update posted2021-01-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)
Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal

Exclusion criteria

Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
Have a known clinically significant gastric emptying abnormality
Have had an episode of severe hypoglycemia
Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
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 3X upper limit of normal (ULN) at screening and/or Day -2

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

Safety / tolerability / PK
3
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Mean Daily Plasma Glucose (PG)

Time frame:Baseline through Day 80

change from baseline, improvement

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): Area Under the Concentration Versus Time Curve of LY3437943

Time frame:Baseline through study completion (12 weeks)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3437943

Time frame:Baseline through study completion (12 weeks)

Cmax

concentration, descriptive

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.