A Study of LY3841136 in Japanese Participants With Obesity or Overweight
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT06297616
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to learn about the side effects of LY3841136 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. The study will last about 28 weeks and may include up to 17 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: LY3841136 LY3841136 LY3841136 administered subcutaneously (SC) Part A: Placebo LY3841136-Placebo Placebo administered SC Part B: Tirzepatide + LY3841136-Placebo LY3841136-Placebo Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC Part B: Tirzepatide + LY3841136-Placebo Tirzepatide Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC Part B: LY3841136 + Tirzepatide-Placebo LY3841136 LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC Part B: LY3841136 + Tirzepatide-Placebo Tirzepatide-Placebo LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC Part B: LY3841136 + Tirzepatide LY3841136 LY3841136 administered SC along with Tirzepatide administered SC Part B: LY3841136-Placebo + Tirzepatide-Placebo LY3841136-Placebo Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC Part B: LY3841136-Placebo + Tirzepatide-Placebo Tirzepatide-Placebo Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC Part B: LY3841136 + Tirzepatide Tirzepatide LY3841136 administered SC along with Tirzepatide administered SC
- Primary Outcome Measures
Name Time Method 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 Baseline through 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
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 Baseline through 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
- Secondary Outcome Measures
Name Time Method Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 Predose through Week 22 PK: AUC of LY3841136 alone
Part A PK: Maximum Observed Concentration (Cmax) of LY3841136 Predose through Week 22 PK: Cmax of LY3841136 alone
Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12 Baseline through Week 12 PD: Change from baseline in body weight
Part B PK: AUC of LY3841136 in Combination with Tirzepatide Predose through Week 34 PK: AUC of LY3841136 in combination with tirzepatide
Part B PK: Cmax of LY3841136 in Combination with Tirzepatide Predose through Week 34 PK: Cmax of LY3841136 in combination with tirzepatide
Part B PD: Change From Baseline in Body Weight at Week 24 Baseline through Week 24 PD: Change from baseline in body weight
Trial Locations
- Locations (3)
P-One Clinic
🇯🇵Hachioji, Tokyo, Japan
Sumida Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Hakata Clinic
🇯🇵Fukuoka, Japan