A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination with Tirzepatide, in Japanese Participants with Obesity or Overweight (J3R-JE-YDAB)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly Japan K.K.
- Enrollment
- 128
- Primary Endpoint
- 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
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to 65age old under (—)
- Sex
- All
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
- •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
Outcomes
Primary Outcomes
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
Time Frame: 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
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
Time Frame: 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 Outcomes
No secondary outcomes reported