The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
P-One Clinic
Hachiōji, Tokyo, Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan
Hakata Clinic
Fukuoka, Japan
Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through Week 22
Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through Week 34
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
PK: AUC of LY3841136 alone
Time frame: Predose through Week 22
Part A PK: Maximum Observed Concentration (Cmax) of LY3841136
PK: Cmax of LY3841136 alone
Time frame: Predose through Week 22
Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12
PD: Change from baseline in body weight
Time frame: Baseline through Week 12
Part B PK: AUC of LY3841136 in Combination with Tirzepatide
PK: AUC of LY3841136 in combination with tirzepatide
Time frame: Predose through Week 34
Part B PK: Cmax of LY3841136 in Combination with Tirzepatide
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Administered SC
PK: Cmax of LY3841136 in combination with tirzepatide
Time frame: Predose through Week 34
Part B PD: Change From Baseline in Body Weight at Week 24
PD: Change from baseline in body weight
Time frame: Baseline through Week 24