Obesity Overweight
Conditions
Interventions
DRUG: LY3841136
Administered SC
DRUG: LY3841136-Placebo
Administered SC
DRUG: Tirzepatide
Administered SC
DRUG: Tirzepatide-Placebo
Administered SC
Experimental: Part A: LY3841136
LY3841136
Sponsors
Wakayama Naohiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female participants who agree to contraception requirements Have a body mass index (BMI) within the range of 27 to 40 kg/m2, inclusive Have had a stable weight for the 3 months
Exclusion criteria
Exclusion criteria: Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus Have a history of chronic medical conditions involving the heart, liver, or kidneys Have a history of any malignancy within the past 5 years Have a history or presence of a GI disorder Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening For participants in Part B, have previously received tirzepatide within 6 months prior to screening For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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] | — |
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed