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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 128
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Part B: LY3841136 + Tirzepatide-Placebo
LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
Intervention: Tirzepatide-Placebo (Drug)
Part A: LY3841136
LY3841136 administered subcutaneously (SC)
Intervention: LY3841136 (Drug)
Part A: Placebo
Placebo administered SC
Intervention: LY3841136-Placebo (Drug)
Part B: Tirzepatide + LY3841136-Placebo
Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
Intervention: LY3841136-Placebo (Drug)
Part B: Tirzepatide + LY3841136-Placebo
Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
Intervention: Tirzepatide (Drug)
Part B: LY3841136 + Tirzepatide-Placebo
LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
Intervention: LY3841136 (Drug)
Part B: LY3841136 + Tirzepatide
LY3841136 administered SC along with Tirzepatide administered SC
Intervention: LY3841136 (Drug)
Part B: LY3841136 + Tirzepatide
LY3841136 administered SC along with Tirzepatide administered SC
Intervention: Tirzepatide (Drug)
Part B: LY3841136-Placebo + Tirzepatide-Placebo
Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC
Intervention: LY3841136-Placebo (Drug)
Part B: LY3841136-Placebo + Tirzepatide-Placebo
Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC
Intervention: Tirzepatide-Placebo (Drug)
Outcomes
Primary Outcomes
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
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
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
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
- Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136(Predose through Week 22)
- Part A PK: Maximum Observed Concentration (Cmax) of LY3841136(Predose through Week 22)
- Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12(Baseline through Week 12)
- Part B PK: AUC of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
- Part B PK: Cmax of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
- Part B PD: Change From Baseline in Body Weight at Week 24(Baseline through Week 24)