DRUG
LY3437943
Administered SC
Status
Completed
Phase
Phase 1
Enrollment
64
Locations
4
Results
Not posted
Publications
0
Study summary
The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Mar 30, 2021
Study start
May 24, 2021
Primary completion
Jun 23, 2022
Study completion
Jun 23, 2022
Results posted
Not reported
Registry updated
Aug 22, 2022
Outcomes
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
Time frame · Predose on Day 1 through Day 81
PK: Cmax of LY3437943
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943
Time frame · Predose on Day 1 through Day 81
PK: AUC of LY3437943
Change from Baseline in Mean Daily Plasma Glucose (PG)
Time frame · Baseline through Day 80
Change from baseline in mean daily PG from 6-point PG profile
Change from Baseline in Glycated Hemoglobin (HbA1c)
Time frame · Baseline through Day 78
Change from Baseline in HbA1c
Change from Baseline in Fasting Glucose
Time frame · Baseline through Day 78
Change from Baseline in Fasting Glucose
Change from Baseline in Body Weight
Time frame · Baseline through Day 78
Change from Baseline in Body Weight
Eligibility
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).
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
P-one clinic
Hachiōji, Tokyo, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan
Yokohama Minoru Clinic
Yokohama, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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